Related Experiment Video

Updated: Jan 21, 2026

Objective Nociceptive Assessment in Ventilated ICU Patients: A Feasibility Study Using Pupillometry and the Nociceptive Flexion Reflex
06:04

Objective Nociceptive Assessment in Ventilated ICU Patients: A Feasibility Study Using Pupillometry and the Nociceptive Flexion Reflex

Published on: July 4, 2018

9.2K

Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients (COMIC): a pilot randomised controlled

Kimberley Lewis1, Sarah Culgin2, Roman Jaeschke1,3

  • 1Department of Medicine, McMaster University, Hamilton, Ontario, Canada.

BMJ Open
|July 22, 2019
PubMed

Insights

This pilot study evaluates the Cuff Leak Test (CLT) for predicting airway obstruction after extubation in intensive care unit (ICU) patients. It assesses the feasibility of using CLT results to guide extubation decisions and improve patient outcomes.

Area of Science:

  • Critical Care Medicine
  • Respiratory Medicine
  • Clinical Trials

Background:

  • Endotracheal intubation and mechanical ventilation are common ICU interventions.
  • Laryngeal edema is a potential complication leading to airway obstruction post-extubation.
  • The Cuff Leak Test (CLT) is the sole available predictor, but its accuracy is uncertain.

Purpose of the Study:

  • To pilot a randomized controlled trial (RCT) assessing the utility of the CLT in mechanically ventilated ICU patients.
  • To determine the feasibility of using CLT results to guide extubation decisions.
  • To gather data for a larger definitive trial on airway obstruction prediction.

Main Methods:

  • A multicentered, pragmatic pilot RCT enrolling 100 mechanically ventilated ICU patients.
  • Patients randomized 1:1 to either communicate CLT results to physicians or withhold results.
  • Feasibility outcomes include consent, recruitment, and adherence; clinical outcomes include postextubation stridor and reintubation.

Main Results:

  • The primary outcomes are feasibility metrics: consent rate, recruitment rate, and protocol adherence.
  • Secondary clinical outcomes include postextubation stridor, reintubation, need for surgical airway, and mortality.
  • The study aims to inform the design of a future, larger COMIC RCT.

Conclusions:

  • This pilot trial protocol outlines a pragmatic approach to evaluating the CLT's clinical utility.
  • Findings will guide the methodology for a definitive RCT on predicting airway obstruction post-extubation.
  • The study addresses a critical gap in predicting a common and serious ICU complication.
Abstract

Keywords:
cuff leak testlaryngeal edemapilot trialrandomized controlled trial

More Related Videos

Mechanical Ventilation Boot Camp Curriculum07:36

Mechanical Ventilation Boot Camp Curriculum

Published on: March 12, 2018

10.6K
Laryngeal Mask Airway LMA Placement in a Neonatal Patient Simulator Using a Non-Inflatable Supraglottic Airway SGA04:56

Laryngeal Mask Airway LMA Placement in a Neonatal Patient Simulator Using a Non-Inflatable Supraglottic Airway SGA

Published on: July 14, 2023

4.8K

Related Concept Videos

Mechanical Ventilation II: Invasive Ventilation01:23

Mechanical Ventilation II: Invasive Ventilation

Ventilators are essential medical equipment used to aid patients with respiratory difficulties. Their primary function is to assist or replace spontaneous breathing by providing mechanical ventilation. There are two general classes of mechanical ventilators: negative-pressure and positive-pressure ventilators.
Negative-Pressure Ventilators
Negative-pressure ventilators create a vacuum around the chest or body to draw air into the lungs, simulating breathing. This method does not require an...
657
Mechanical Ventilation III: Noninvasive Ventilation01:23

Mechanical Ventilation III: Noninvasive Ventilation

Noninvasive positive-pressure ventilation (NIPPV), continuous positive airway pressure (CPAP), and bilevel positive airway pressure (BiPAP) are essential methods in respiratory care. These ventilation techniques offer unique benefits for patients with various respiratory conditions, providing adequate support without requiring intubation. Let's explore how each method is crucial in improving patient outcomes and enhancing respiratory therapy.
Noninvasive Positive-Pressure Ventilation...
536
Mechanical Ventilation I: Indication and Settings01:29

Mechanical Ventilation I: Indication and Settings

Mechanical ventilation is a life-saving technique for managing acute respiratory failure and other respiratory complications. The process involves using a machine known as a ventilator to supply oxygen to the lungs and assist in removing carbon dioxide. It serves as a bridge to long-term mechanical ventilation or a temporary measure until ventilatory support is discontinued. The ventilator can maintain this function for a prolonged period, providing critical support for patients until they can...
2.7K
Pilot and Numeric Relaying01:21

Pilot and Numeric Relaying

Pilot relaying is a type of differential protection used in power systems. It compares electrical quantities at the terminals of equipment via a communication channel instead of direct relay interconnection. This method is essential for transmission lines where the terminals are far apart, typically up to 80 km for lines with 69 to 115 kV ratings. Four types of communication channels are used for pilot relaying:
483
Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
10.2K
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
4.6K