| Sumario: | Introduction: Laryngeal edema is a known complication of intubation that may cause airway obstruction in patients upon extubation. The only test available to predict this complication is the cuff leak test (CLT), however, its diagnostic accuracy and clinical utility remains uncertain. We conducted the Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients (COMIC) pilot study to determine the feasibility of undertaking a larger trial. Methods: COMIC is an international multicentred, parallel-group randomised clinical trial (RCT). Mechanically ventilated adults from three centers admitted to the ICU who were deemed ready for extubation were enrolled. All patients had a CLT done prior to extubation. The intervention arm communicated CLT results to the team, who decided whether-or-not to proceed with extubation. The CLT results for the control arm were not communicated to the team and patients were extubated, regardless of the CLT. Primary outcomes focused on feasibility, including consent rate, recruitment rate and protocol adherence. Results: 100 patients were enrolled. All feasibility criteria were met including: (i) recruitment rate of 7.6 patients/month, (ii) consent rate of 88.3%, and (iii) protocol adherence of 98%. There were two episodes of clinically significant stridor in the intervention group, and four patients required reintubation per group. Conclusion: Although the CLT is a non-invasive test used to predict laryngeal edema and post- extubation stridor there are no RCTs to determine the impact of CLT on patient-important outcomes. The COMIC pilot found that it is feasible to conduct a powered RCT on the use of CLT in the ICU. Although underpowered to determine the effect of the CLT on clinical outcomes, there were no alarming differences in reintubations, or emergency surgical airways between the two pilot groups. A large RCT will help us to understand the risk and benefit of the CLT in critical illness.
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