**5. Optovue-RTVue 100 glaucoma scanning protocol**

In glaucoma research, four scanning models for the Optovue-RTVue spectral domain OCT (RTVue Optovue Inc. Fremont, CA) device are used.

circular RNFL area whose center is the optic disc head and the RNFL area located at the rim

OCT in Glaucoma Diagnosis, Detection and Screening http://dx.doi.org/10.5772/intechopen.78683 163

This scan is used to analyze the RNFL and it has shown that RNFL parameters of the RTVue-100°CT has good specificity for the detection of glaucoma [45]. The RNFL scanning pattern completes four circular scans with diameters of 3.45 mm in 0.16 s by aiming for the optic disc head. The average of these four scans is calculated and the result is presented with normative parameters. The RNFL thickness profile at the optic disc head is the circular RNFL thickness with a diameter of 3.45 mm, which is the central optic disc and not the center of the scan itself. Ultimately, cases where the optic disc is decentralized do not affect the measurements. The RNFL thickness map is exhibited at the lower right area and the areas that are measured to be thin have a

darker color while areas that are measured to be thick have a lighter color (**Figure 5**).

RNFL and the optic disc head parameters are located at the left section.

In the lower right section, there is the thickness profile. Here, the RNFL thickness profile is charted temporally, superiorly, nasally, inferiorly and temporally again, in that order, beginning from around the optic disc. This thickness profile is charted as a black line by being superimposed on normative data (so that values within the normal range remain in the greenshaded area, while values outside of the normal range remain in the red-shaded area). The

of the optic disc, 2 mm away.

**Figure 5.** RNFL scan in RTVue.

**5.3. RNFL scan**

#### **5.1. Optic disc scanning**

The optic disc is calculated through a 6 × 6 mm cube consisting of 101 lines. 3D optic disc scanning is used especially for the formation of reference lines and the determination of optic disc veins. The 3D reference line represents the optic disc limits created automatically by a software that uses the 3D optic disc scan.

#### **5.2. Map of the optic disc head**

In this protocol, 13 circular and 9 radial scans with 1.3–4.9 mm diameters around the optic disc head are performed. These scans limit the area between the retinal pigment epithelium and the optic disc head. Here, the device automatically calculates the center of the optic disc and not the center of the scan itself. The same calculation is also automatically used in progression maps (**Figure 4**).

The map of the optic disc head provides significant information about the morphology of the optic disc. It provides insight, especially on the cup-to-disc ratio of the optic disc, the 3.45 mm

**Figure 4.** Optic disc head map in RTVue.

circular RNFL area whose center is the optic disc head and the RNFL area located at the rim of the optic disc, 2 mm away.

#### **5.3. RNFL scan**

This scan is used to analyze the RNFL and it has shown that RNFL parameters of the RTVue-100°CT has good specificity for the detection of glaucoma [45]. The RNFL scanning pattern completes four circular scans with diameters of 3.45 mm in 0.16 s by aiming for the optic disc head. The average of these four scans is calculated and the result is presented with normative parameters.

The RNFL thickness profile at the optic disc head is the circular RNFL thickness with a diameter of 3.45 mm, which is the central optic disc and not the center of the scan itself. Ultimately, cases where the optic disc is decentralized do not affect the measurements. The RNFL thickness map is exhibited at the lower right area and the areas that are measured to be thin have a darker color while areas that are measured to be thick have a lighter color (**Figure 5**).

In the lower right section, there is the thickness profile. Here, the RNFL thickness profile is charted temporally, superiorly, nasally, inferiorly and temporally again, in that order, beginning from around the optic disc. This thickness profile is charted as a black line by being superimposed on normative data (so that values within the normal range remain in the greenshaded area, while values outside of the normal range remain in the red-shaded area). The RNFL and the optic disc head parameters are located at the left section.

**Figure 5.** RNFL scan in RTVue.

**Figure 4.** Optic disc head map in RTVue.

**5. Optovue-RTVue 100 glaucoma scanning protocol**

(RTVue Optovue Inc. Fremont, CA) device are used.

software that uses the 3D optic disc scan.

**5.2. Map of the optic disc head**

gression maps (**Figure 4**).

**5.1. Optic disc scanning**

162 OCT - Applications in Ophthalmology

In glaucoma research, four scanning models for the Optovue-RTVue spectral domain OCT

The optic disc is calculated through a 6 × 6 mm cube consisting of 101 lines. 3D optic disc scanning is used especially for the formation of reference lines and the determination of optic disc veins. The 3D reference line represents the optic disc limits created automatically by a

In this protocol, 13 circular and 9 radial scans with 1.3–4.9 mm diameters around the optic disc head are performed. These scans limit the area between the retinal pigment epithelium and the optic disc head. Here, the device automatically calculates the center of the optic disc and not the center of the scan itself. The same calculation is also automatically used in pro-

The map of the optic disc head provides significant information about the morphology of the optic disc. It provides insight, especially on the cup-to-disc ratio of the optic disc, the 3.45 mm

#### **5.4. RNFL glaucoma progression report**

The RNFL 3.45 protocol identifies the RNFL thickness of the peripapillary area by performing circular scans with a diameter of 3.45 mm around the optic disc. What is important here is the sum of four 1024-A scans performed in 0.15 s, that is, the data of 4096 scans in total.

of the same cell are located at the inner plexiform layer and as this layer is affected, the inner plexiform layer gets thinner. So, the GCC scan measures the thickness of each of these three

OCT in Glaucoma Diagnosis, Detection and Screening http://dx.doi.org/10.5772/intechopen.78683 165

Another advantage of the GCC thickness analysis is the macula's inclusion of the 50% of the ganglion cells in the retina. However, NFL is very thin in the macula and since NFLs change places to form a foveal cup there are none of them in the foveola. In the perifoveal region, the

The scan includes 12 vertical lines and 1 horizontal line with a length of 7 mm. These lines are placed 0.5 mm away from each other and are focused on the temporal of the 1 mm fovea so that they include as many ganglion cells as possible. With this scan, the thickness map and the

The deviation map illustrates the deviations of normal values for different ages and races that are available in the normative database. The significance map reports the findings for the patient by comparing them with the normal values in the normative database on the basis of race. Red, yellow and green colors are used to note the differences in the follow-ups. It demonstrates the significance level or the statistical significance of the deviation when compared with a normal value. In short, the significance map demonstrates how significant the differ-

Another parameter here is the focal loss volume (FLV), which gives us the significant loss of GCC numerically. FLV is the sum of the significant loss of GCC topography, in terms of volume and is expressed as a percentage. At the same time, FLV is the most sensitive parameter which provides the difference between normal eyes and glaucomatous eyes (it is more

As it can be seen, while RTVue provides an excellent assessment of the ganglion cell layer it also allows a comparison to be made with the normal values, based on age and race. In follow-ups, progression analysis by RTVue compares the RNFL thickness measurements and the GCC map over time and thus, determines whether statistically significant changes have

The GCC progression report displays a total of four scans at the same time for both eyes, one of which is basal and the remaining three are for follow-ups. The output is divided into four sections. The first three sections are the GCC thickness map, the deviation map and the significance map. The GCC thickness map is the one coded with colors indicating the GCC thickness of the macular region. The deviation map is the one coded with colors indicating the loss percentages that the device determined according to the normal values based on the normative database. The significance map is the one demonstrating the statistically significant changes in comparison to the normal values by coding them in green, yellow and red colors. Finally, the fourth section includes the average, superior and inferior GCC chart. In this scan, the GCC thickness of the lower and upper hemisphere of the entire retina is scanned by excluding the foveal ring. Scan data are presented as changes between the basal scan and the

NFL is very thin but the ganglion cell layer and the IPL are much thicker [47, 48].

layers which are affected by the glaucoma [46].

ence is compared to the normal value.

occurred or not [1, 26, 49].

**5.6. GCC glaucoma progression report**

last scan, calculated in microns.

sensitive than the GCC thickness parameters).

abnormal changes in the inner retina can be demonstrated.

The RNFL output is divided into three sections. In the first section, regional RNFL thickness results are demonstrated with basal RNFL values and RNFL values of each subsequent check. The second section demonstrates the comparative TSNIT chart of RNFL, which is defined by a double hump pattern. The third section includes the value chart for average, superior and inferior RNFL. In addition, it illustrates the scans for each follow-up as a table including the changes between the basal scan and the last scan calculated in microns.

### **5.5. The map of the ganglion cell complex (GCC)**

The GCC scan has provided new parameters for the diagnosis of glaucoma. The nerve fiber layer (NFL), the ganglion cell layer and the inner plexiform layer (IPL) make up the GCC in the macular area. Today, more emphasis is placed on GCC rather than the thickness of the whole retina in the diagnosis of glaucoma [44]. In studies regarding this issue, it has been shown that glaucoma mostly thins the nerve fibers, the ganglion cells and the IPL; and the inner nuclear layer at an intermediate level and that it does not affect the outer layers [44]. The GCC study is quite useful for the early diagnosis of glaucoma and the determination of the disease's progression, since the loss of ganglion cells occur before the visual pathway lesions and thinning of the nerve fibers [13]. RTVue, by having a mapping protocol of macular ganglion cell complex, exhibits a positive value in detecting glaucoma.

The GCC thickness is defined as the distance consisting of three inner retinal layers (nerve fiber layer, ganglion cell layer and the inner plexiform layer) beginning from the inner limiting membrane and ending at the inner plexiform layer. (**Figure 6**) All three layers are affected in glaucoma [44].

When the ganglion cells die, the ganglion cell layer gets thinner and when the axon nerve fiber layer which is a part of this cell is damaged, the nerve fiber layer gets thinner. The dendrites

**Figure 6.** Anatomy of ganglion cell complex (GCC).

of the same cell are located at the inner plexiform layer and as this layer is affected, the inner plexiform layer gets thinner. So, the GCC scan measures the thickness of each of these three layers which are affected by the glaucoma [46].

Another advantage of the GCC thickness analysis is the macula's inclusion of the 50% of the ganglion cells in the retina. However, NFL is very thin in the macula and since NFLs change places to form a foveal cup there are none of them in the foveola. In the perifoveal region, the NFL is very thin but the ganglion cell layer and the IPL are much thicker [47, 48].

The scan includes 12 vertical lines and 1 horizontal line with a length of 7 mm. These lines are placed 0.5 mm away from each other and are focused on the temporal of the 1 mm fovea so that they include as many ganglion cells as possible. With this scan, the thickness map and the abnormal changes in the inner retina can be demonstrated.

The deviation map illustrates the deviations of normal values for different ages and races that are available in the normative database. The significance map reports the findings for the patient by comparing them with the normal values in the normative database on the basis of race. Red, yellow and green colors are used to note the differences in the follow-ups. It demonstrates the significance level or the statistical significance of the deviation when compared with a normal value. In short, the significance map demonstrates how significant the difference is compared to the normal value.

Another parameter here is the focal loss volume (FLV), which gives us the significant loss of GCC numerically. FLV is the sum of the significant loss of GCC topography, in terms of volume and is expressed as a percentage. At the same time, FLV is the most sensitive parameter which provides the difference between normal eyes and glaucomatous eyes (it is more sensitive than the GCC thickness parameters).

As it can be seen, while RTVue provides an excellent assessment of the ganglion cell layer it also allows a comparison to be made with the normal values, based on age and race. In follow-ups, progression analysis by RTVue compares the RNFL thickness measurements and the GCC map over time and thus, determines whether statistically significant changes have occurred or not [1, 26, 49].

#### **5.6. GCC glaucoma progression report**

**Figure 6.** Anatomy of ganglion cell complex (GCC).

in glaucoma [44].

**5.4. RNFL glaucoma progression report**

164 OCT - Applications in Ophthalmology

The RNFL 3.45 protocol identifies the RNFL thickness of the peripapillary area by performing circular scans with a diameter of 3.45 mm around the optic disc. What is important here is the

The RNFL output is divided into three sections. In the first section, regional RNFL thickness results are demonstrated with basal RNFL values and RNFL values of each subsequent check. The second section demonstrates the comparative TSNIT chart of RNFL, which is defined by a double hump pattern. The third section includes the value chart for average, superior and inferior RNFL. In addition, it illustrates the scans for each follow-up as a table including the

The GCC scan has provided new parameters for the diagnosis of glaucoma. The nerve fiber layer (NFL), the ganglion cell layer and the inner plexiform layer (IPL) make up the GCC in the macular area. Today, more emphasis is placed on GCC rather than the thickness of the whole retina in the diagnosis of glaucoma [44]. In studies regarding this issue, it has been shown that glaucoma mostly thins the nerve fibers, the ganglion cells and the IPL; and the inner nuclear layer at an intermediate level and that it does not affect the outer layers [44]. The GCC study is quite useful for the early diagnosis of glaucoma and the determination of the disease's progression, since the loss of ganglion cells occur before the visual pathway lesions and thinning of the nerve fibers [13]. RTVue, by having a mapping protocol of macular

The GCC thickness is defined as the distance consisting of three inner retinal layers (nerve fiber layer, ganglion cell layer and the inner plexiform layer) beginning from the inner limiting membrane and ending at the inner plexiform layer. (**Figure 6**) All three layers are affected

When the ganglion cells die, the ganglion cell layer gets thinner and when the axon nerve fiber layer which is a part of this cell is damaged, the nerve fiber layer gets thinner. The dendrites

sum of four 1024-A scans performed in 0.15 s, that is, the data of 4096 scans in total.

changes between the basal scan and the last scan calculated in microns.

ganglion cell complex, exhibits a positive value in detecting glaucoma.

**5.5. The map of the ganglion cell complex (GCC)**

The GCC progression report displays a total of four scans at the same time for both eyes, one of which is basal and the remaining three are for follow-ups. The output is divided into four sections. The first three sections are the GCC thickness map, the deviation map and the significance map. The GCC thickness map is the one coded with colors indicating the GCC thickness of the macular region. The deviation map is the one coded with colors indicating the loss percentages that the device determined according to the normal values based on the normative database. The significance map is the one demonstrating the statistically significant changes in comparison to the normal values by coding them in green, yellow and red colors. Finally, the fourth section includes the average, superior and inferior GCC chart. In this scan, the GCC thickness of the lower and upper hemisphere of the entire retina is scanned by excluding the foveal ring. Scan data are presented as changes between the basal scan and the last scan, calculated in microns.

#### **5.7. RTVue OCT normative database**

The normative database of RTVue OCT is the largest OCT normative database. As mentioned earlier, these databases allow to distinguish between normal cases and pathological ones. In this database, there are a total of 1600 eyes, 600 of which are from the USA and 1000 of which are from around the world. The data allow us to compare the measurements of the patients with measurements of other patients in the same age group. In the display coded with colors, green (normal), yellow (doubtful) and red (abnormal) are used.

It must be noted that comparisons with normative databases are only for statistical purposes and there may be normal people with values that are outside the normal range.


**3. Results and Discussions**

*3.1. Synthesis of CuI Nanostructured Materials*

CuI powdered materials show a fine powder consistency and light creamy color. A high yield of the synthesis reaction was observed (>90%). White homogeneous colloidal suspensions of CuI were also fabricated (Figure 2). The colloids show stability for about two weeks. There are no significant differences in the appearance of the colloidal suspensions, concerning the polymer employed. The absence of greenish-blue tonalities confirms the reduction of Cu 2+to Cu 1+ species.

**Figure 2.** Synthesis of CuI nano-structured materials by a controlled precipitation method followed of reduction. Biopolymer (Arabic gum and chitosan were employed to increase colloidal stability). The materials (powders and colloids) exhibit a white color, characteristic of Cu(I) materials.

#### *3.2. Characterization of CuI Nanostructured Materials*

**SEM-EDX.** Figure 3 shows the SEM characterization of CuI nanostructured materials. At low magnifications, the materials exhibit a shell-like morphology (Figure 3A,C). Figure 3C clearly shows the 3D shell-like architectures with controlled internal microstructures. Figure 3B,D show the materials at higher magnifications. The materials are composed of smaller particles that are orderly aggregated in 3D shell structures. SEM-EDX analysis (Figure 3E,F) reveals the composition and purity of the materials. The weight percentages of the elements are in agreement with a CuI formulation (33.4% Cu and 66.6% I). Figure S1 (Supplementary information) shows a representative micrograph of CuI with the corresponding EDX elemental mapping for copper and iodine. Only Cu and I are present and well dispersed in the CuI lattice, demonstrating the successful preparation of the material.

**Figure 3.** SEM-EDX analysis of CuI powdered nano-structured materials. (**A**) low magnification SEM micrograph of CuI powdered material, the shell like morphology of the materials is easily seen. (**B**) high magnification SEM micrograph of CuI powdered material, illustrating the ordered nanostructures that compose the 3D shell microstructures. (**C**) magnification of dotted zone in A. (**D**) magnification of dotted zone in B. (**E**) SEM micrograph for EDX analysis. (**F**) EDX analysis of CuI powdered materials.

**AFM.** Figure 4 portrays the AFM analyses of AG and CuI@AG thin films. Figure 4A–C show the morphology of AG films. The polymeric films (AG) are very thin (≈4 nm) and exhibit a uniform structure and composition. In comparison, CuI@AG films are thicker (≈30 nm) due to the insertion of CuI NMs in the polymeric matrix (Figure 4D–F). AFM analysis confirms the shell morphology of the CuI materials observed with SEM analysis. Tapping phase analysis (Figure 4C) of AG demonstrates the presence of pure polymer, while the CuI@AG phase analysis (Figure 4F) denotes phase changes due to inorganic (CuI) and organic (polymer) composition [21].

**Figure 4.** AFM analysis of Arabic gum (AG) and CuI@AG films. (**A**–**C**) Arabic gum thin films; height, amplitude and phase analysis, respectively. (**D**–**F**) CuI@AG thin films; height, amplitude and phase analysis, respectively.

AFM analyses of chitosan and CuI@Ch films are presented in Figure 5. Twodimensional topography analysis of chitosan is shown in Figure 5A, illustrating its smooth surface and homogeneity. Figure 5D–L display the height, amplitude, and phase images of CuI@Ch composites at increasing magnifications. The AFM images at low magnifications reveal the presence of uniformly distributed CuI nanostructured materials with shell-like morphology. At higher magnification, a detailed inspection of the composite nanostructure denotes the presence of small (≈50 nm) ordered particles with a hierarchical 3D shell-like morphology.

In tapping mode, phase analysis is capable of imaging the nanostructure of blend or multiphase materials with high resolution of submicron length scales. We can observe evident differences in the phase images of chitosan films (Figure 5C) in comparison to CuI@Ch films. For Ch films, only one phase is observed, corresponding to the biopolymer, whereas for the composite, inorganic (CuI) and organic (polymer) phases are represented.

**Figure 5.** AFM analysis of Chitosan (Ch) and CuI@Ch films. (**A**–**C**) Chitosan thin films; Height, amplitude and phase analysis respectively. (**D**–**L**) CuI@Ch composite films; height, amplitude and phase analysis at different magnifications.


**1. Introduction**

In the past twenty years, US DoD has been undergoing three major transformations concerning the way to (i) fight, (ii) conduct business, and (iii) collaborate with allied countries. These transformations have led to significant changes in US DoD acquisition process, moving away from requirement-based to capability-based acquisition, the adaptation of the Joint Capability Integration & Development System (JCIDS) and Systems-of-Systems perspective in the design and build of future space systems [1–6]. **Figure 1** illustrates the key differences between the requirement-based and capability-based approaches. The red dotted line shown in **Figure 1** denotes the area of responsibility between the US Government (USG)1 and its selected contractor. For requirement-based, the US DoD is responsible for (i) defining the reference system architecture, architecture performance attributes (APAs) and associated key performance parameters (KPP), and architecture trade-space, and (ii) developing Level-A specifications (spec) that can potentially

1 Practically, USG team refers pre-Milestone A acquisition activities as the pre-award phase in the US Department of Defense (DoD) acquisition life cycle.

#### **Figure 1.**

*Description of requirement-based and capability-based approaches.*

achieving optimum KPP within the defined trade-space. A selected defense contractor is responsible for using the Level A spec to derive lower level requirements (subsystems and components), design and build the system.

Unlike requirement-based approach, the capability-based approach requires USG to define user objectives and provide required capabilities for meeting warfighter needs. As shown in **Figure 1**, USG is also responsible for providing technical objectives and goals documents along with the Initial Capability Document (ICD)2 that presents APAs, required capabilities, threshold, and objective criteria for meeting the required capabilities. On the other hand, a selected contractor is responsible for defining the architecture trade space and developing appropriate "TBD" documents for the derivation of Level A spec using the USG's ICD and inputs (e.g., evolving adversary threats, existing US DoD systems' capabilities, etc). The "TBD" documents shown in **Figure 1** are dependent on the acquisition phase. The "TBD" document can be a Capability Development Document (CDD) or a Revised-CDD3 . Like requirement-based approach, the selected contractor is also responsible for the (i) flow-down of Level A spec to lower level requirements, and (ii) design and build of the systems. For some defense system acquisition programs, USG also provides Technical Requirement Document (TRD) or System Requirement Document (SRD) along with the ICD to help the selected contractor concentrates on specific operational use cases, APAs and KPPs.

Designing a system for operation in complex Systems-of-Systems environment requires a good understanding of the types of systems-of-systems that the designed system would be operated in. There are three types of Systems-of-Systems, namely, Type 1: A family of System-of-Systems that provides similar core services, e.g., communication services - But each system provides different core service types, e.g., non-secure FDMA vs. secure TDMA communication services; Type 2: An integration of many families of System-of-Systems, when combined, this type of system provides unique Systems-of-Systems capabilities at the enterprise level (i.e., integrated level) - An example of this complex system is a combination of a family

2 Per JCIDS process, the required system capabilities are usually provided in ICD.

3 Formerly known as Capability Production Document.

#### *Systems-of-Systems MS&A for Complex Systems, Gaming and Decision for Space Systems DOI: http://dx.doi.org/10.5772/intechopen.100007*

of communications Systems with a family of Global Position Satellite systems; and Type 3: An integration of many heterogenous, independent but interrelated types of systems with each system providing distinctive core services.

As pointed out in [7], most of current professional papers, technical reports and System-of-Systems standards considered integration of (i) many systems of the same type of systems together, which is identical to Type 1, and (ii) many different types of systems as a system consisted of many systems and referred to as Systemof-Systems, which is identical to Type 3. In this chapter, we focus our discussion on Type 2, since existing System-of-Systems engineering standards and current MS&A approaches can be directly applied to Type 1 and Type 3 but not Type 2.

This chapter presents advanced concepts on systems-of-systems MS&A approaches to support capability-based acquisition of defense space systems. The MS&A frameworks and processes presented here are emphasized on the systemsof-systems architecture trade support phase of the US DoD defense acquisition life cycle. In addition, it addresses systems-of-systems MS&A frameworks, processes, models and tools using game theoretical modeling and DSS for developing optimum acquisition strategy to acquire complex systems. The complex systems discussed in this chapter are mainly focused on defense space systems, but they can be extended to any systems-of-systems for civilian and commercial applications.

The chapter is organized as follow: (i) Section 2 presents an advanced capabilitybased MS&A framework, including processes and required MS&A tools, to support US DoD acquisition life cycle from the system architecture design phase to sustainment phase; (ii) Section 3 describes a MS&A approach supporting architecture design and analysis of complex systems using systems-of-systems perspective; (iii) Section 4 provides a MS&A approach for acquisition strategy development and optimization supporting pre-award phase; (iv) Section 5 describes existing available systems-ofsystems MS&A models and tools supporting the pre-award phase of the acquisition life cycle; and (v) Section 6 concludes the chapter with a conclusion and way-forward.


**4.7 Gas chromatography-flame ionization detector (GC-FID) analysis**

The gas chromatography-flame ionization detector (GC-FID) was conducted to measure the degradation rate of the bacteria strains. The bacteria strains were grown back using enrichment culture method in different tubes and each tube was harvested on day 0, day 3, day 6, day 9 and day 12. Next, 1 ml of ethyl acetate was added to 1 ml of each sample and the mixture is vortex for around 10 seconds until a double layer could be observed from the mixture. Then the upper layer was pipetted into a vial tube [35]. The samples were then analyzed using gas chromatography-flame ionization detector machine and the data was collected. The degradation percentage were calculated using the formula given below. The percentage of residual substrate are calculated first using the Eq. 1. Once the percentage is obtained, the degradation percentage are calculated using the formula in Eq. 2.

Percentage of residual substrate : ðaverage peak area average controlÞ � 100 ¼ % (1)

Degradation percentage : 100 � Percentage of residual substrate ¼ X% (2)


**4. Monte Carlo calculations**

For this work, we use the MCNPX version: 2.70 (license: C00810MNYCP) originally developed in the Los Alamos laboratory (Radiation Safety Information Computer Center, US). With the visual Editor VisedX\_24E, this edition includes the package MCNP6.1/MCNP5–1.60/MCNPX-2.7.0. In addition, different tools were used for geometry modeling, particles transport, and 3D viewing of the defined geometry for the source and detectors with a dynamic model of simulation. To define the dosimetric parameters, MCNPX has different tallies to estimate each type of calculation. We consider the 60Co source used this study composed of two gamma energies: 1.173 MeV and 1.332 MeV. The radiation spectrum of the 192Ir source used was obtained from the database of (National Nuclear Data Center) neglecting the β spectrum for both of the simulated sources, since its contribution to the dose rate distribution is negligible due to the encapsulation [6, 16]. The Monte Carlo code fulfills all the recommendations of the report, "Dosimetric prerequisites for routine clinical use of photons emitting brachytherapy sources with average energy higher than 50 keV" of the AAPM and ESTRO. The following compilation options were used: CHEAP, DEC, PLOT, MCPLOT, GKSSIM, XS64, CEM, INCL, HISTP, MESHTAL, RADIOG, and SPABI. The physic models of MCNPX used in this study operating the new updated photons and electrons, the photons cross sections libraries mcplib02 and mcplib84 updated from mcplib04 photon Compton broadening data for MCNP5 [17], and the el03 for electrons.


**3.2. Prerequisites for successful esophageal speech**

This method creates a new air reservoir used for speech within the esophagus of a lower capacity than the physiological one, which is the source of the sound wave. The capacity of the upper part of the esophagus after surgery is 60–80 ml of air [18], and the sound wave is generated by vibrations of the pharyngoesophageal segment in neoglottis, which allows the production of the esophageal voice. The exact localization of the pharyngoesophageal segment vibrations differs from author to author, and vibrations are possible from the base of the tongue to the upper esophageal sphincter, but most authors suggest that the most common vibrations of the pharyngoesophageal cavity vibration are at the level of the fifth, sixth and seventh cervical vertebrae, while Seeman feels that vibrations are at the level of the cricopharyngeal muscle at the height of the fifth cervical vertebra or where the pharyngoesophageal obstruction is the greatest [17].

In order for alaryngeal phonation to be possible (production of speech without the larynx), an appropriate tonus of pharyngoesophageal segment, more precisely the cricopharyngeal muscle, is needed. In determining the degree of tonus available, today there are two evaluation tools:

When using Taub's Insufflation Test, the examiner places the nasal catheter into the esophagus, using the Polyzer balloon to insufflate the air to the catheter. If the tonus is appropriate, the patient will be able to phonate, and the test will then record a positive result. The reference limit of the phonation pressure is 22 mmHg, which allows the 10 s alaryngeal phonation, or speech production in the range of 10–15 syllables in one inspiration. The phonation pressure is measured with a manometer. In cases where there is hypertonicity, the patient is not able to produce an alaryngeal voice, and the test registers a negative result [19].

The self-blowing test (modified Taube test) has been used for 33 years and was invented by Blom and Singer. The difference is that the other end of the nasal catheter is introduced into the tracheostoma and in this way allows an independent insufflation of the air from the tracheostoma to the esophagus. The result is recorded as positive when the patient can alaryngeally phonate for at least 8 s [20].

The negative result in these tests indicates undesirable hypertonicity of the muscle which prevents the phonation, and requires surgical intervention in the form of cricopharyngeal myotomy [20]. Muscle hypotonicity is also undesirable because it may interfere with alaryngeal phonation, but it often results in a very weak intensity of the alaryngeal voice. As the voice of low intensity does not meet the daily communication requirements, the hypotonicity can be compensated by external compression or surgical intervention.

In addition to the appropriate muscular tonus of the pharyngoesophageal segment, the person who will be rehabilitated with the esophageal speech must have a satisfactory level of certain cognitive abilities. Considered among the most important cognitive abilities are the appropriate intellectual status and the motivation of a person, but the conative factors are also significant. When choosing modality, psychosocial and socioeconomic factors are also important. The person who will learn the esophageal speech should be highly motivated for the process of rehabilitation, be patient enough, cognitively superior, and live in an empathetic and supportive family and social environment. Socioeconomic status should be as high as necessary for regular attendance at a speech-language therapy in continuity. Regarding the health status, people who will learn the esophageal speech should be of a good general health and somatic status, and the primary disease should be under good local control, which means removing any suspicion of local recurrence. Certainly, a significant influence on the possibility of this modality has the auditory status of the patient, and the level of hearing should be appropriate to the chronological age of the person, at the hearing level of 20–55 dB [5]. Any hearing impairment above 55 dB affects the communication function significantly and disables the adequate reception of the information from the speech-language therapist, thereby making it difficult and slowing down the process of rehabilitation.

Doyle classified contraindications for the learning of the esophageal speech in four categories [17, 21, 22]:

**1.** Certain physical factors

method an esophageal speech [17]. The method is the most natural way for the laryngectomized persons to have the alaryngeal phonation, which has made it the most commonly used method for many years. Although satisfying a number of factors is a prerequisite, Seeman considers the appropriate level of motivation to be the key factor for mastering the esophageal speech, and that most motivated patients successfully adopt this mode of substitution [17].

This method creates a new air reservoir used for speech within the esophagus of a lower capacity than the physiological one, which is the source of the sound wave. The capacity of the upper part of the esophagus after surgery is 60–80 ml of air [18], and the sound wave is generated by vibrations of the pharyngoesophageal segment in neoglottis, which allows the production of the esophageal voice. The exact localization of the pharyngoesophageal segment vibrations differs from author to author, and vibrations are possible from the base of the tongue to the upper esophageal sphincter, but most authors suggest that the most common vibrations of the pharyngoesophageal cavity vibration are at the level of the fifth, sixth and seventh cervical vertebrae, while Seeman feels that vibrations are at the level of the cricopharyngeal muscle at the height of the fifth cervical vertebra or where the pharyngoesophageal

In order for alaryngeal phonation to be possible (production of speech without the larynx), an appropriate tonus of pharyngoesophageal segment, more precisely the cricopharyngeal muscle, is needed. In determining the degree of tonus available, today there are two evalua-

When using Taub's Insufflation Test, the examiner places the nasal catheter into the esophagus, using the Polyzer balloon to insufflate the air to the catheter. If the tonus is appropriate, the patient will be able to phonate, and the test will then record a positive result. The reference limit of the phonation pressure is 22 mmHg, which allows the 10 s alaryngeal phonation, or speech production in the range of 10–15 syllables in one inspiration. The phonation pressure is measured with a manometer. In cases where there is hypertonicity, the patient is not able to

The self-blowing test (modified Taube test) has been used for 33 years and was invented by Blom and Singer. The difference is that the other end of the nasal catheter is introduced into the tracheostoma and in this way allows an independent insufflation of the air from the tracheostoma to the esophagus. The result is recorded as positive when the patient can alaryn-

The negative result in these tests indicates undesirable hypertonicity of the muscle which prevents the phonation, and requires surgical intervention in the form of cricopharyngeal myotomy [20]. Muscle hypotonicity is also undesirable because it may interfere with alaryngeal

produce an alaryngeal voice, and the test registers a negative result [19].

**3.2. Prerequisites for successful esophageal speech**

obstruction is the greatest [17].

70 Esophageal Cancer and Beyond

• Taub's insufflation test.

geally phonate for at least 8 s [20].

• Modified Taub's test.

tion tools:

	- the presence of psychological problems and psychopathology.
	- inability to attend a therapy at least three times a week.
	- immediately after laryngectomy, the necessity to speak loudly for a certain reason.

#### **3.3. Functional features of the esophageal speech**

The acoustic parameters of the esophageal voice in the literature vary depending on the researchers, the selected research method, the measuring instrument, the measuring criteria, the sample of subjects, and the environmental and computer program conditions in which the measurement was performed. The fundamental frequency, or the height of the esophageal voice, is reduced, the frequency range is reduced, and the acoustic parameters determining the timbre of the voice also differ significantly from the regular laryngeal voice [5, 23, 24]. Such values of acoustic parameters form a rough and breathy voice, subjectively experienced. In addition, the time for turning on the voice is prolonged and the maximum time of the phoning is significantly reduced. According to prosodic features, the melody of the esophageal voice is more uniform and variable, lexical stress is not realized or is partially realized, frequent undesirable respiratory pauses are often present and the tempo of speaking is slower [5].

on the correct technique of injecting speech air into the esophagus, and the other is based on the proper technique of eructation of speech air. **Figure 1** shows the scheme of esophageal

The Role of Esophagus in Voice Rehabilitation of Laryngectomees

http://dx.doi.org/10.5772/intechopen.78594

73

There are several different methods of introducing speech air into the esophagus used in clinical speech therapy, namely: deglutition, inhalation, injection, blocking, Portman's, Tartapan's,

In 1900, Gottstein created and described the deglutition/swallowing method, and Gutzmann supplemented and propagated it. The method requires inserting the required air for the alaryngeal phonation according to the principle of swallowing or air ingestion as a bolus which causes eructation. This is considered the initial method because it allows a volitional ructus, but it affects the rhythm of speech and substantially slows it down, which is its disadvantage. As air swallowing, that is, "dry swallowing" is limited, it is recommended to consume the

In 1922, Seeman described the inhalation method, also referred to as aspirational or suctioning method. It requires a few swift inhalations that cause a sudden drop in intraoral pressure, which allows aspiration of air from the oral cavity into pharynx, and into the esophagus and relaxation of the pharyngoesophageal segment. When the pressures get equal, the air suction is stopped, the aspirated air is eructated and sounded through the pharyngoesophageal segment. Initially, the vocals are articulated, followed by the syllables made of a combination of gutural/h/ and vocals. Sometimes, the use of the method is followed by hyperventilation.

The injectable or occlusive method was formed by collecting the experiences of patients who noticed that the easiest way for them to loudly articulate occlusives and syllables combined from occlusives and vocals is alaryngeally. The method requires sufficient pressure of the tongue which causes air compression in the oral cavity and pharynx and is injected into the

There are several modifications of this method in the world.

voice production.

and their combinations [5, 17, 22].

fluid during therapy [17].

**Figure 1.** Esophageal voice production.

Sociofunctional features of the esophageal voice, which also make the advantage of this rehabilitation modality are: both hands free during speech and being less noticeable to the environment during speech, spontaneous and natural way of alaryngeal speech without additional surgery and insertion of foreign bodies, independence of prosthetic aids, the ability to speak without high consumption of material resources. On the other hand, the features that make up its shortcomings are: long periods of rehabilitation, lack of regular and continuous attendance at rehabilitation, discontinuous speech and additional undesirable noise during speech, especially tracheal noise during inspiration, which interfere with the intelligibility of the pronounced words [25].


**5. Conclusion**

The Ishikawa diagram is an effective tool for discovering the sources of problems in enterprises. It allows to classify and establish a hierarchy of a set of various statements, causes of faults, in a situation where this set is chaotic. However, it gives the opportunity to look at the production or activity of the company from the point of view of many areas that are often not suspected of affecting the broadly understood quality. When using the diagram, however, you may encounter difficulties:

Difficulties can also arise when determining root causes using the 5 Whys:

The examples shown illustrate different production situations. A similar approach could be taken in many areas, for example, in the area of Man, by identifying the causes of errors inherent in the human mentality and mental and physical condition. Sometimes, the Ishikawa diagram was modified to include other issues, such as those related to computer operation and data flow. You can also encounter a situation when 5 Whys leads to a surprising discovery of the negligence of the employer, or draws attention to a seemingly insignificant problem that—as it turned out in point 4.3—can affect the health of employees.

Based on the examples, it can be concluded that the knowledge of manufacturing technology always plays a key role. However, in the production process, the subject is man, and his behavior determines the course of this process. Finally, it should be emphasized that the production process and its improvement should start with the management. The lack of awareness of the management and the lack of management skills can have a negative impact and manifest in the lack of training, motivation, and incentives for professional development of employees. Thus, it is difficult to talk about quality management of products and processes.


*Supporting open minds since 2005*

Environmental Management - Pollution, Habitat, Ecology, and Sustainability http://dx.doi.org/10.5772/intechopen.94788 Edited by John P. Tiefenbacher

#### Contributors

Lameed Gbolagade Akeem, Lateef Funmilayo Lewiska, Yogranjan Singh, Sarthak Pandey, Amit Kumar Goswami, Percy Jinga, Gerard Rushingabigwi, Celestin Twizere, Jean De Dieu Ntawangaheza, Liguo Sun, Philibert Nsengiyumva, Michael Thomas Aide, Indi Braden, Christine Aide, Rodrigue Constant Sandjong Sani, Mama Ntoupka, Toua Vroumsia, Adamou Ibrahima, Muniyandi Balasubramanian, Rabindra Kumar Mishra, Barun Kumar Behera, Anita Dash, Bidyut Kumar Patra, Andy Vinten, Iain D.M. Gunn, Tabbsum Hanif Mujawar, Lalasaheb Deshmukh, P. Prabhakar, Vijendra Chaudhari, Abdelkader Anouzla, Mlika Kastali, Latifa Mouhir, Abdelaziz Madinzi, Salah Souabi, Abdeslam Taleb, Neha Agarwal, Shubhagato Dasgupta, Latief Mahir Rachman, Michel Soto Chalhoub, Farida Hanna Campbell, Enes Yasa, Kadir Özdemir

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**5. Conclusion**

which leads to more advancement of PICC line. This can be avoided by using rope method of measurements (can use a nasogastric tube or any flexible tubes) along the course of

**3.** Before insertion, make sure the catheter tip is not bent or curved, which is proposed to cause more damage to the vessel wall and vascular erosion. If the catheter is inappropriately placed in the intracardiac position, it can cause pericardial tamponade and pleural

**4.** Central venous catheter insertion should be done under strict cardiac monitoring with properly placed ECG leads. Performing physician should monitor the ECG wave patterns carefully especially while introducing the catheter beyond brachiocephalic vein. If any mild changes are observed in the ECG, the catheter should be withdrawn immediately. **5.** If the introducer feels the cardiac pulsations in the catheter or the slightest resistance dur-

**6.** Fix the catheter with the exact measurement. One should avoid increasing 1 or 2 cm more,

**7.** Confirmation of catheter positioning with radiography should be done immediately after the insertion of catheters. Optimizing a good position of the neonate is mandatory (**Table 5**). The interaction between the neonatal posture, and radiological catheter position is well

**8.** Always aim to place the catheter in an optimal position. The ideal position is 0.5–1 cm away from the cardiac outline in preterm and 1–2 cm away from the cardiac outline in term neonates. Confirmation by ultrasound is upcoming and it is welcoming advancement in neonatal care [15]. Real-time ultrasound has been shown to have good diagnostic utility in comparison with X-ray with sensitivity of 95–96.5% and specificity of 100% in neonates [18–20].

**9.** Know the catheter tip position. Identify it in each X-ray and if it needs adjustments, per-

**10.** Prevention of catheter migration is at most important by application of the secure transparent dressing. Secure it with proper measurement and document the external catheter length. External length needs to be verified in each shift. Proper hand over by the concerned staff nurse is mandatory to notify the migration early. Repeated pump occlusion

**11.** Arrhythmic complications can occur anytime from the time of insertion to the time of removal of catheters. Any neonate with the catheter in situ developed arrhythmia could

Upper extremity X-ray Keep both arms and forearms straight Over the sides of the neonate

assuming that can later withdraw it after confirming the position with X-ray.

veins applicable to lower and upper extremity veins.

ing the pathway, the catheter should be withdrawn immediately.

form the amendments. Do not ever forget to document it.

**Table 5.** Ideal positions for X-rays pertaining to different sites of PICC line [10].

effusion secondary to the curved catheter.

172 Cardiac Arrhythmias

explained in advances in neonatal care.

alarms could be a sign of migration [13].

Lower extremity X-ray Keep both legs straight

Central line insertion is a very common bedside procedure in NICU setup, it is not uncommon to encounter complications. Although there are various complications related to PICC line insertion, arrhythmic complications are preventable by exact measurements along the venous course, avoidance of willful over advancement of the catheter, prevention of migration and early detection of migration and adjusting the catheter tip properly. Ultrasoundguided insertion of catheter and placement of catheter tip using real-time ultrasonography is a welcoming advancement to minimize arrhythmic complications. Worldwide, the reported incidence of arrhythmic complications published in the literatures are few.


Biological Characteristics of Native Grape Cultivars of Crimean Region and Availability of Their Use in Breeding

*Svetlana Levchenko, Irina Vasylyk, Vladimir Volynkin, Vladimir Likhovskoy and Alla Polulyakh*