Clinical trial NCT05456542: Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients
Official title: Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients (COSMIC): A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Failure
Keywords: Laryngeal Edema, Mechanical Ventilation, Cuff Leak Test
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
Collaborators: name: Hamilton Academic Health Sciences Organization
First posted: 2022-07-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentred, national, parallel-group, pragmatic vanguard pilot trial.
Primary purpose: DIAGNOSTIC

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

Detailed 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).

Eligibility criteria: 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 week defined 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 admitted to 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 listed above. 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 in airway injury

Exclusion Criteria:

* Palliative care plan or plan of care does not include re-intubation, Decision to withdraw 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 inhalation injuries, blunt or penetrating trauma of the neck and airway, recent head and neck surgeries, and patients admitted with airway edema
* Known pre-existing tracheolaryngeal abnormalities: Vocal cord paralysis, tracheolaryngeal neoplasm, tracheomalasia, tracheolaryngeal stenosis, or previous head and neck surgeries
* Mechanical ventilation via a tracheostomy
* High dose steroids administered within the previous 72h (Prednisone 1mg/kg oral equivalent)
* The ICU physician believes the patient should have a CLT performed
* Patient had a failed CLT in the previous 24 hours

Primary outcomes:
measure: Protocol Adherence
timeFrame: 30 days
measure: Recruitment Rate
timeFrame: 1 Year
Secondary outcomes:
measure: Proportion of patients with Clinically Significant post-extubation stridor
timeFrame: within 72 hours of extubation;
measure: Proportion of patients Reintubation
timeFrame: within 72 hours of extubation;
measure: Proportion of patients with Post-extubation stridor
timeFrame: within 72 hours of extubation
measure: Proportion of patients with Emergency Surgical Airway
timeFrame: within 72 hours of extubation
measure: ICU Mortality
timeFrame: Within 30 days of Randomization
measure: Hospital Mortality
timeFrame: Within 30 days of Randomization
measure: Ventilator Free Days
timeFrame: Within 30 Days of Randomization
measure: ICU Length of Stay
timeFrame: Within 30 days of Randomization
measure: Length of Stay
timeFrame: Within 30 days of Randomization
measure: Proportion of patients with Ventilator Associated Pneumonia
timeFrame: 30 Days from Randomization
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Brantford
country: Canada
facility: Brantford General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: St. Catherines
country: Canada
facility: Niagara Health System
state: Ontario
city: Kuwait City
country: Kuwait
facility: Al-Amiri Hospital
Study officials:
affiliation: St. Joseph's Healthcare Hamilton
name: Dr. Kimberley Lewis, MD
role: PRINCIPAL_INVESTIGATOR
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