Recruitment
RECRUITMENT, COMPLICATIONS
Given the large number of surgical interventions performed under general anaesthesia at the study centres involved each day and only little restrictive inclusion and exclusion criteria, insufficient numbers of potential study participants are not to be expected. Because the additional burden on the participants while participating in the study is deemed to be manageable, a high recruitment rate can be assumed. We do not expect substantial problems with protocol adherence due to the short duration of the intervention.Randomization takes place automatically through computer-aided generation of random numbers, which are translated into a randomization decision and will be triggered online by the respective investigator on the day of the intervention at the earliest, so that a concealed allocation to the interventions is ensured (allocation concealment). The randomization result will be communicated non-verbally to the anaesthetist and the nursing staff involved via a display on the tablet monitor to ensure that the patient remains blinded.The generation of the allocation sequences and the allocation to the individual intervention arms takes place via an IT-based system (OpenClinica, Waltham, MA, USA) coordinated by the Center for Clinical Studies of the German Association of Anaesthesiology and Intensive Care (DGAI).If the anaesthetist in charge of the intervention decides not to leave the choice of the intubation instrument to chance for medical reasons before the induction of anaesthesia and prior to randomization, the participation in the trial for this patient and the case will be considered a “screening failure”. If such a decision (deviating from the randomization result) is made after the patient has been randomized but before the start of the first intubation attempt, the first intubation attempt will be.considered to have failed. These cases will be reported separately in the study flow chart. The remainder of intervention as per protocol remains unaffected. After a first intubation attempt with the randomized laryngoscopy device, the anaesthetist performing the procedure is free to change the instrument at his/her own discretion. The required intubation attempts and the time to successful intubation are recorded as described above.In addition, the study protocol does not make any specifications for handling possible complications in securing the airway. The physician carrying out the intervention always has unrestricted authority to make medical decisions to prevent harm to the patient without affecting the patient’s participation in the study.