Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients

Respiratory Failure Clinical Trial

— COSMIC  

Official title:

Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients (COSMIC): A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05456542
• Other study ID #: 3480
• Status: Recruiting
• Phase: Phase 3
• Start date: April 5, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: November 2023
• Source: St. Joseph's Healthcare Hamilton
• Contact: Jose Estrada
• Phone: 905-522-1155
• Email: jestrada[@]stjosham.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Airway Obstruction
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Diagnostic Test:
• Cuff Leak Test
Clinicians perform the cuff leak test (CLT) to help optimize extubation. The test requires deflation of the cuff at the end of the endotracheal tube (ETT) and auscultation for air passing around the ETT. If air movement is not audible on auscultation (a failed CLT) there is a potential presence of laryngeal edema (LE) that may cause post-extubation airway obstruction.

Drug:
• Dexamethasone 4mg
Dexamethasone, will be administered to those patients who fail the CLT in the intervention arm (4mg intravenous every 6 hours for 12-24 hours). Dexamethasone belongs to a class of drugs known as corticosteroids

Locations

Country	Name	City	State
Canada	Brantford General Hospital	Brantford	Ontario
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario
Kuwait	Al-Amiri Hospital	Kuwait City

Sponsors (2)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton	Hamilton Academic Health Sciences Organization

Countries where clinical trial is conducted

Canada,  Kuwait, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protocol Adherence	Define a successful adherence rate as =75%. We will calculate the adherence as the proportion of patients that are assigned to the intervention arm following the appropriate treatment algorithm and those assigned to the control arm being extubated without a cuff leak test. As this pilot trial is ongoing, we will review adherence monthly and investigate the reasons for compliance failure. We will investigate all reasons for failure to follow the treatment algorithm in the intervention arm, failure to extubate after a patient passes a CLT in the intervention arm, or failure to extubate immediately after randomization in the control arm and report them as a protocol violation. The RC will review the RT's charting and the medication profile to determine actual compliance. RC will record all reasons for non-compliance using distinguishing clinical reasons (eg, palliation, death, consent withdrawal and errors).	30 days
Primary	Recruitment Rate	Define a successful recruitment rate as enrolling three patients per centre per month over the duration of the trial. While the pilot trial is ongoing, steering committee will review recruitment weekly and the screening records monthly. If applicable, we will address barriers to enrolment to maximise recruitment. The recruitment metric will be measured and interpreted at the end of the pilot trial by calculating the mean number of recruited patients per active screening month.	1 Year
Secondary	Proportion of patients with Clinically Significant post-extubation stridor	Defined as the presence of an inspiratory noise following extubation that requires medical intervention such as racemic epinephrine	within 72 hours of extubation;
Secondary	Proportion of patients Reintubation	Re insertion of an endotracheal tube to maintain an airway within 72 hours for any reason (reasons for reintubation will be captured)	within 72 hours of extubation;
Secondary	Proportion of patients with Post-extubation stridor	Defined as the presence of an inspiratory noise following extubation.	within 72 hours of extubation
Secondary	Proportion of patients with Emergency Surgical Airway	A procedure performed to secure the airway in patients with upper airway obstruction who could not be managed with intubation or mechanical ventilation.	within 72 hours of extubation
Secondary	ICU Mortality	Death during Intensive Care Unit admission	Within 30 days of Randomization
Secondary	Hospital Mortality	Death during Intensive Care Unit admission	Within 30 days of Randomization
Secondary	Ventilator Free Days	Number of days alive and free of mechanical ventilation.	Within 30 Days of Randomization
Secondary	ICU Length of Stay	Number of days admitted to the ICU	Within 30 days of Randomization
Secondary	Length of Stay	Number of days admitted to hospital	Within 30 days of Randomization
Secondary	Proportion of patients with Ventilator Associated Pneumonia	Pneumonia occurring more than 48 h after patients have been intubated and received mechanical ventilation.	30 Days from Randomization

External Links

•   Trial Website