Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients

Completed · Phase 3

Conditions studied: Respiratory Failure

In brief

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

Key facts

Study ID

NCT05456542

Run by

St. Joseph's Healthcare Hamilton

People needed

100

Starts

2023-04-05

Expected to finish

2025-01-06

Last updated by the study team

2025-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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

You may not qualify if…

• 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

Where it is running

• The University of Texas Health Science Center at Houston — Houston, Texas, United States
• Brantford General Hospital — Brantford, Ontario, Canada
• St. Joseph's Healthcare Hamilton — Hamilton, Ontario, Canada
• Niagara Health System — Saint Catherines, Ontario, Canada
• Al-Amiri Hospital — Kuwait City, Kuwait

Full record on ClinicalTrials.gov

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