Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients

Last updated: March 5, 2025
Sponsor: St. Joseph's Healthcare Hamilton
Overall Status: Completed

Phase

3

Condition

Bronchiectasis

Respiratory Failure

Lung Injury

Treatment

Dexamethasone 4mg

Cuff Leak Test

Clinical Study ID

NCT05456542
3480
  • Ages > 18
  • All Genders

Study Summary

The COSMIC trial will be a multicentred, national, parallel-group, pragmatic vanguard pilot trial.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥18 yrs. of age

  • Mechanically ventilated in the ICU \

  • An order to extubate has been provided by the treating physician

  • Meet at least 1 criteria for risk factors for Laryngeal Edema(LE):

  • Criteria 1

  • Intubated for >5 days

  • Criteria 2 *must fulfill category 1 and ≥1 risk factor in category 2

  • Category 1

  • Intubated for >48 hours

  • Category 2

  • An unplanned extubation event within the last week

  • Airway trauma secondary to an endotracheal intubation during the past weekdefined as one of the following:

  • More than one attempt at direct laryngoscopy

  • More than one attempt to pass the ETT

  • Charted as a traumatic intubation

  • A body mass index of >30kg/m2

  • An endotracheal tube greater than 8mm in a man or 7mm in a woman

  • A total positive cumulative fluid balance of at least >1500ml/d x # of days admittedto ICU (eg. If admitted for 4 days, the patient will meet this criterion if they are 6L positive during their length of ICU admission)

  • Physician concern about possible laryngeal edema for a reason not previously listedabove. For example:

  • Prone or Trendelenburg position in a recent operation

  • Agitation defined as a RASS of 3+ or more or a SAS of 6 or more that may result inairway injury

Exclusion

Exclusion Criteria:

  • Palliative care plan or plan of care does not include re-intubation, Decision towithdraw life support, or no plan for re-intubation

  • Known pregnancy: Current pregnancy or up to and including 7 days postpartum

  • Patients with highly suspected laryngeal injury: Burn patients, smoke inhalationinjuries, blunt or penetrating trauma of the neck and airway, recent head and necksurgeries, and patients admitted with airway edema

  • Known pre-existing tracheolaryngeal abnormalities: Vocal cord paralysis,tracheolaryngeal neoplasm, tracheomalasia, tracheolaryngeal stenosis, or previoushead and neck surgeries

  • Mechanical ventilation via a tracheostomy

  • High dose steroids administered within the previous 72h (Prednisone 1mg/kg oralequivalent)

  • The ICU physician believes the patient should have a CLT performed

  • Patient had a failed CLT in the previous 24 hours

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Dexamethasone 4mg
Phase: 3
Study Start date:
April 05, 2023
Estimated Completion Date:
January 06, 2025

Study Description

The COSMIC trial will be a multicentred, national, parallel-group, pragmatic vanguard pilot trial in adults (≥18 years) who are mechanically ventilated in the ICU with risk factors for LE and an order to extubate has been provided by the treating physician.

The aims of this study are to assess:

  1. Protocol adherence

  2. Recruitment rates

  3. Secondary clinical outcomes will be collected, and if feasibility criteria are met, ultimately used in the powered trial pending no major protocol adjustments (otherwise will be reported as cohort data).

Connect with a study center

  • Brantford General Hospital

    Brantford, Ontario
    Canada

    Site Not Available

  • Juravinski Hospital

    Hamilton, Ontario
    Canada

    Site Not Available

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario L8N 4A6
    Canada

    Site Not Available

  • Niagara Health System

    St. Catherines, Ontario L2S 0A9
    Canada

    Site Not Available

  • Al-Amiri Hospital

    Kuwait City,
    Kuwait

    Site Not Available

  • King Fahad Hospital of the University

    Khobar, Eastern Province
    Saudi Arabia

    Site Not Available

  • King Abdulaziz Medical City

    Riyadh,
    Saudi Arabia

    Site Not Available

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Site Not Available

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