RESULTS
desaturation, ARF
ARF, SECONDARY, RECRUITMENT
A total of 123 consecutive patients who had been under invasive mechanical
ventilation for at least 48 hours before extubation were randomized for the study.
One included participant presented a distorted MRC measurement at inclusion due to
sedation. Consequently, he did not reach a major eligibility criterion and was
excluded from the analysis. Thus, analysis for the primary outcome was performed
with data from 122 patients, and in the secondary analyses, a maximum of 121
patients was considered (
Study flow chart.Recruitment was stopped in January 2015 after an effectiveness interim analysis at
50% of inclusions by a Data and Safety Monitoring (DSMB) committee. The DSMB
reviewed the results of 123 patients and recommended stopping the study due to the
low incidence of ARF in both groups and the lack of benefits in any major secondary
outcome. Furthermore, they concluded that even if the sample size was attained, the
probability of finding a significant difference in the primary outcome would be only
6.64%.After extubation, a total of 463 sessions were performed: 231 in the control group
and 232 in the MI-E Group, and only 54 patients (23.4%) in each group received the 4
preprogrammed sessions. Only one patient presented a desaturation during a session
in the Control Group. In the MI-E Group, the majority of the sessions were performed
with an insufflation pressure set at +40cmHDemographic and clinical characteristics of patients with intensive care
unit-acquired weakness at baseline Data completely missing for one patient after 61 patients were included
in this group. Results expressed as median (interquartile range 25% -
75%), n (%) or n.