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

Primary Purpose

Respiratory Failure

Status

Not yet recruiting

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Cuff Leak Test

Dexamethasone 4mg

About this trial

This is an interventional diagnostic trial for Respiratory Failure focused on measuring Laryngeal Edema, Mechanical Ventilation, Cuff Leak Test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Brantford General Hospital
St. Joseph's Healthcare Hamilton
Juravinski Hospital
King Fahad Hospital of the University
King Abdulaziz Medical City

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention - Cuff Leak Test

Control - No Cuff Leak Test

Arm 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.

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.

Outcomes

Primary Outcome Measures

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).

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.

Secondary Outcome Measures

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

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)

Proportion of patients with Post-extubation stridor

Defined as the presence of an inspiratory noise following extubation.

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.

ICU Mortality

Death during Intensive Care Unit admission

Hospital Mortality

Death during Intensive Care Unit admission

Ventilator Free Days

Number of days alive and free of mechanical ventilation.

ICU Length of Stay

Number of days admitted to the ICU

Length of Stay

Number of days admitted to hospital

Proportion of patients with Ventilator Associated Pneumonia

Pneumonia occurring more than 48 h after patients have been intubated and received mechanical ventilation.

Full Information

NCT ID

NCT05456542

First Posted

May 3, 2022

Last Updated

July 12, 2022

Sponsor

St. Joseph's Healthcare Hamilton

Collaborators

Hamilton Academic Health Sciences Organization

1. Study Identification

Unique Protocol Identification Number

NCT05456542

Brief Title

Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients

Acronym

COSMIC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 1, 2022 (Anticipated)

Primary Completion Date

May 30, 2024 (Anticipated)

Study Completion Date

November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

St. Joseph's Healthcare Hamilton

Collaborators

Hamilton Academic Health Sciences Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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: Protocol adherence Recruitment rates 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Failure

Keywords

Laryngeal Edema, Mechanical Ventilation, Cuff Leak Test

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Multicentred, national, parallel-group, pragmatic vanguard pilot trial.

Masking

Outcomes Assessor

Masking Description

The Research Coordinator will randomize eligible patients in a 1:1 allocation using undisclosed variable block sizes through a central computer system on REDCap. Randomization algorithm will stratify patients by recruitment site. This is an unblinded study as group allocation will be known. However, outcome adjudicators and the study statistician will be blinded to the group allocation.

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention - Cuff Leak Test

Arm Type

Experimental

Arm Description

Arm Title

Control - No Cuff Leak Test

Arm Type

No Intervention

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

Cuff Leak Test

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Dexamethasone 4mg

Intervention Description

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

Primary Outcome Measure Information:

Title

Protocol Adherence

Description

Time Frame

30 days

Title

Recruitment Rate

Description

Time Frame

1 Year

Secondary Outcome Measure Information:

Title

Proportion of patients with Clinically Significant post-extubation stridor

Description

Defined as the presence of an inspiratory noise following extubation that requires medical intervention such as racemic epinephrine

Time Frame

within 72 hours of extubation;

Title

Proportion of patients Reintubation

Description

Re insertion of an endotracheal tube to maintain an airway within 72 hours for any reason (reasons for reintubation will be captured)

Time Frame

within 72 hours of extubation;

Title

Proportion of patients with Post-extubation stridor

Description

Defined as the presence of an inspiratory noise following extubation.

Time Frame

within 72 hours of extubation

Title

Proportion of patients with Emergency Surgical Airway

Description

A procedure performed to secure the airway in patients with upper airway obstruction who could not be managed with intubation or mechanical ventilation.

Time Frame

within 72 hours of extubation

Title

ICU Mortality

Description

Death during Intensive Care Unit admission

Time Frame

Within 30 days of Randomization

Title

Hospital Mortality

Description

Death during Intensive Care Unit admission

Time Frame

Within 30 days of Randomization

Title

Ventilator Free Days

Description

Number of days alive and free of mechanical ventilation.

Time Frame

Within 30 Days of Randomization

Title

ICU Length of Stay

Description

Number of days admitted to the ICU

Time Frame

Within 30 days of Randomization

Title

Length of Stay

Description

Number of days admitted to hospital

Time Frame

Within 30 days of Randomization

Title

Proportion of patients with Ventilator Associated Pneumonia

Description

Pneumonia occurring more than 48 h after patients have been intubated and received mechanical ventilation.

Time Frame

30 Days from Randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sarah Culgin, MSc

Phone

905-522-1155

sculgin@stjoes.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Kate Nelson, MSc

nelsonk@stjoes.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kimberley Lewis, MD

Organizational Affiliation

St. Joseph's Healthcare Hamilton

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brantford General Hospital

City

Brantford

State/Province

Ontario

Country

Canada

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brenda Reeves, MD

First Name & Middle Initial & Last Name & Degree

Brenda Reeves, MD

Facility Name

St. Joseph's Healthcare Hamilton

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 4A6

Country

Canada

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sarah Culgin, MSc

sculgin@stjoes.ca

First Name & Middle Initial & Last Name & Degree

Kimberley Lewis, MD

Facility Name

Juravinski Hospital

City

Hamilton

State/Province

Ontario

Country

Canada

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bram Rochwerg, MD

First Name & Middle Initial & Last Name & Degree

Bram Rochwerg, MD

Facility Name

King Fahad Hospital of the University

City

Khobar

State/Province

Eastern Province

Country

Saudi Arabia

Facility Name

King Abdulaziz Medical City

City

Riyadh

Country

Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

http://comictrial.com

Description

Trial Website

Learn more about this trial

Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients

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