Clinicians perform the cuff leak test (CLT) to help optimize extubation. The test requires deflation of the cuff at the end of the endotracheal tube (ETT) and auscultation for air passing around the ETT. If air movement is not audible on auscultation (a failed CLT) there is a potential presence of laryngeal edema (LE) that may cause post-extubation airway obstruction. Approximately 4-55% of mechanically ventilated ICU patients will have some degree of LE and upwards of 50% of those patients will require emergent reintubation for airway protection. Predicting patients that are unsuitable for extubation is important as reintubation itself is associated with increased morbidity and mortality.
While the CLT is a simple, non-invasive, and inexpensive test, its diagnostic accuracy, and therefore clinical applicability, remains uncertain. A failed CLT and presumptive diagnosis of LE is often treated with systemic corticosteroids and a delay in extubation. Therefore, a false positive test will result in an unnecessary delay in extubation. Current guidelines reflect the uncertainty in the evidence. The American Thoracic Society issued a conditional recommendation based on very low certainty of evidence to perform a CLT on those with risk factors for LE.
Given the current variation in practice, and prior to embarking on a largescale RCT, we wanted to determine if mandating physicians to use or withhold the CLT was feasible. We therefore conducted the COMIC pilot trial. We included mechanically ventilated adults admitted to the ICU who were deemed ready for extubation at the discretion of the clinical team. The COMIC pilot trial met all feasibility thresholds including a consent rate of 88.3%, a recruitment rate of 7.6 patients per month, and a protocol adherence of 98%.
Given the success of COMIC with all feasibility criteria met, we have decided to move forward with the “Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients (COSMIC): A Randomized Controlled Trial”. Armed with the lessons from COMIC, our objective is to complete a vanguard trial.

About COSMIC

How is COSMIC different from COMIC?
There are significant protocol changes that resulted after learning from the COMIC pilot study.
See below for differences and justification:
