Discussion
ADVERSE EVENTS, RECRUITMENT
The extubation decision-making process has been carried out based on the result of a spontaneous breathing test, irrespective of the results of the predictive indices (The decision to use the T-piece, the strategy usually employed in our hospital, instead of the pressure support ventilation (PSV) was made based on observations suggesting that the T-piece simulates a similar ventilatory load as after extubation and therefore assesses the subject's ability to maintain spontaneous breathing under more realistic conditions (The time to collect the data took longer than initially programmed. Like everyone else in the world, we were caught by surprise by the outbreak of the COVID-19 pandemic, which caused a temporary interruption of the study and delayed reaching the initially planned sample. It took the research team six months to become familiar with the management of the COVID-19 patients and to take precautions to prevent contamination during data collection.Consistent with previous studies (In our 12-year experience using the TIE index, adverse events occurred in approximately 5 to 7% of the procedures, none of which were serious (As expected, the time elapsed from the beginning of the decision test until extubation was higher in the T-piece group because of the different duration of the tests. The study design accounts for such a statistically significant difference since the TIE index measurement takes about 60 s, whereas the T-piece trial, around 30 min (No difference was found regarding survival rate and successful weaning rate between the groups in the Kaplan Meier analysis. However, the speed of the extubation process resulting from using the TIE index as a decision-making tool effectively reduced the time the patient was subjected to the stress of the tests. Noticeably, the performance of the TIE index as a decision-making tool for extubation was not inferior to that of the T-piece trial for any of the study's main outcomes, weaning success and mortality.The study had some limitations. Our local Ethics Committee approved the study in February 2017, but due to internal problems, the start of recruitment was delayed. Effective enrollment was started on October 29, 2019 and finished on February 15, 2021. The data were unblinded on March 16 2021, when the analysis was completed and we started writing the manuscript. The use of the T-piece trial could be seen as a limitation, but a recent study showed that weaning outcome when using such a strategy or pressure-support ventilation did not differ (In conclusion, this preliminary study showed that the use of the TIE index as a decision-making tool for extubation was not inferior to a T-piece trial and allowed reducing the time required to make a decision. We believe that a large multicenter randomized controlled trial is needed to substantiate our findings.