Kimberley Lewis1,2, Sarah Culgin3, Roman Jaeschke1,2,3,4, Dan Perri1,5,4, Corry Marchildon4, Kelly Hassall4, Yousef Almubarak6, Wojciech Szczeklik7, Thomas Piraino8, Lehana Thabane2,3, Khaled M Alqahtani9, Abdulazez Alghamdi10, Mohammed Alshahrani6, Waleed Alhazzani1,2. 1. Department of Medicine. 2. Department of Health Research Methods, Evidence, and Impact, and. 3. St. Joseph's Health Research Institute, St. Joseph's Healthcare, Hamilton, Ontario, Canada. 4. St. Joseph's Healthcare, Hamilton, Ontario, Canada. 5. Clinical Pharmacology and Toxicology, McMaster University, Hamilton, Ontario, Canada. 6. Department of Critical Care, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia. 7. Department of Intensive Care and Perioperative Medicine, Jagiellonian University Medical College, Krakow, Poland. 8. St. Michael's Hospital, Toronto, Ontario, Canada. 9. Department of Mathematics, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia; and. 10. Imam Abdulrahman Bin Faisal University Respiratory Therapy Department, King Fahad Hospital of the University, Dammam, Saudi Arabia.
Abstract
Rationale: Laryngeal edema is a known complication of endotracheal intubation that may cause airway obstruction upon extubation. The only test available to predict this complication is the cuff leak test (CLT). Objectives: Given the uncertainty of the CLT's clinical utility, we conducted the COMIC (Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients) pilot study to examine the feasibility of undertaking a larger trial. Methods: COMIC is a multicentered, parallel-group randomized trial performed in Canada, Saudi Arabia, and Poland. We enrolled mechanically ventilated adults admitted to the intensive care unit who were deemed ready for extubation. Those allocated to the intervention arm had the results of their CLT communicated to the healthcare team, who then decided to proceed with extubation or not. In those randomized to the control arm, the CLT results were not communicated to the healthcare team and patients were extubated, regardless of the CLT result. The primary outcomes focused on feasibility. Results: One hundred patients (56 in the intervention and 44 in the control arm) were enrolled. All feasibility criteria were met, including 1) recruitment rate of 7.6 patients/month, 2) consent rate of 88.3% (95% confidence interval [CI], 82.1-94.5%), and 3) protocol adherence of 98% (95% CI, 95-100%). There were two episodes of clinically significant stridor in the intervention group and four patients who required reintubation in each group. Conclusions: The results of the COMIC pilot trial support the feasibility of a larger trial to determine the effect of the CLT on reintubation and clinically important stridor.Clinical trial registered with www.clinicaltrials.gov (NCT03372707).
Rationale: Laryngeal edema is a known complication of endotracheal intubation that may cause airway obstruction upon extubation. The only test available to predict this complication is the cuff leak test (CLT). Objectives: Given the uncertainty of the CLT's clinical utility, we conducted the COMIC (Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients) pilot study to examine the feasibility of undertaking a larger trial. Methods: COMIC is a multicentered, parallel-group randomized trial performed in Canada, Saudi Arabia, and Poland. We enrolled mechanically ventilated adults admitted to the intensive care unit who were deemed ready for extubation. Those allocated to the intervention arm had the results of their CLT communicated to the healthcare team, who then decided to proceed with extubation or not. In those randomized to the control arm, the CLT results were not communicated to the healthcare team and patients were extubated, regardless of the CLT result. The primary outcomes focused on feasibility. Results: One hundred patients (56 in the intervention and 44 in the control arm) were enrolled. All feasibility criteria were met, including 1) recruitment rate of 7.6 patients/month, 2) consent rate of 88.3% (95% confidence interval [CI], 82.1-94.5%), and 3) protocol adherence of 98% (95% CI, 95-100%). There were two episodes of clinically significant stridor in the intervention group and four patients who required reintubation in each group. Conclusions: The results of the COMIC pilot trial support the feasibility of a larger trial to determine the effect of the CLT on reintubation and clinically important stridor.Clinical trial registered with www.clinicaltrials.gov (NCT03372707).