Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients (COSMIC)

St. Joseph's Healthcare Hamilton

Status and phase: Completed; Phase 3

Conditions: Respiratory Failure

Treatments: Drug: Dexamethasone 4mg; Diagnostic Test: Cuff Leak Test

Study type: Interventional

Funder types: Other

Identifiers

NCT05456542

3480

Details and patient eligibility

About

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

Full 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).

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Intervention - Cuff Leak Test

Experimental group

Description:

A respiratory therapist will perform a Cuff Leak Test on all patients prior to extubation. If no air leak is auscultated (a failed CLT), extubation will be delayed. During this time, the patient will receive dexamethasone 4mg intravenous every 6 hours for 12-24 hours and the clinical team will be advised to consider optimizing a patient's fluid status through either diuresis or ultrafiltration if the patient has renal failure. After 12-24 hours, and once the clinical team decides the patient is ready for another extubation attempt, the CLT will be repeated. If the patient fails the CLT again, it will be at the discretion of the clinical team how to proceed (i.e. continue steroid administration, and further delay extubation vs immediately extubating despite a failed CLT) (Figure 3). A passed CLT at any time point will result in immediate extubation.

Treatment:

Diagnostic Test: Cuff Leak Test

Drug: Dexamethasone 4mg

Control - No Cuff Leak Test

No Intervention group

Description:

In the control group, once the patient is deemed ready for extubation by the clinical team, the patient will be extubated without performing a CLT, without administration of corticosteroids, and without delay.