Cuff Leak Test and Airway Obstruction in Mechanically Ventilated Intensive Care Unit Patients: A Pilot Randomized Controlled Clinical Trial
Bibliographic record
Abstract
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 (NCT 03372707).
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.008 | 0.010 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".