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

Primary Purpose

Laryngeal Edema

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cuff Leak Test
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Laryngeal Edema focused on measuring Cuff leak test, Post-extubation airway obstruction, Laryngeal edema

Eligibility Criteria

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

Inclusion Criteria:

  • Eligible patients will be mechanically ventilated adults (>18 years) who are admitted to the ICU and an order to extubate has been provided by the treating physician.

Exclusion Criteria:

  1. A palliative care, a one-way extubation, or a decision to withdraw advances life support order has been written.
  2. Pregnancy.
  3. Patients at high risk for LE: burn patients, smoke inhalation injuries (as defined as singed facial hair or nasal hair, carbonaceous secretions/sputum, and known to be in an enclosed fire), blunt or penetrating trauma involving the neck and airway, postoperative head and neck surgeries, and patients admitted with airway edema to the ICU (e.g; anaphylaxis).
  4. Patients with either a difficult or traumatic endotracheal intubation.
  5. Patients receiving mechanical ventilation via tracheostomy.
  6. Known preexisting tracheolaryngeal abnormalities such as: vocal cord paralysis, tracheolaryngeal neoplasm, tracheomalacia, tracheolaryngeal stenosis, or previous head and neck surgeries.
  7. Patients receiving systemic corticosteroids of greater than 30 mg of PO prednisone or equivalent, within 4 days prior to the decision to extubate.
  8. Patients who failed extubation attempt within the current ICU admission.
  9. History of postextubation airway obstruction.
  10. The ICU physician declined enrolling the patient.
  11. Patient had a failed CLT in the previous 24 hours.

Sites / Locations

  • St Joseph's Hospital
  • Jagiellonian University Medical College
  • Imam Adbulrahman Bin Faisal University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Arm

Control Arm

Arm Description

Patients randomized to the intervention arm will have the results of the Cuff Leak Test (CLT) (whether failed or passed) communicated to the treating physician; the treating physician will decide whether to proceed with extubation or not based on the CLT results. It is at the discretion of the treating physician to provide corticosteroids (4-5 mg of intravenous dexamethasone every six hours for up to 24 hours, with the last dose given one hour preceding extubation) and/or delay extubation by 24 hours should the patient fail the CLT.

In the control arm of this trial; the treating physicians and healthcare workers will be blinded to the results of the Cuff Leak Test (CLT); therefore, the Respiratory Therapist (RT) will proceed with extubation without delay or administering systemic steroid, regardless to the CLT results.

Outcomes

Primary Outcome Measures

Consent Rate
A successful consent rate will be defined as 70% of substitute decision makers (SDMs) or patients approached to consent, choosing to participate in the trial. This will be calculated as the overall proportion of SDMs or patients consenting out of those approached (with 95% CI). Note that a mixed consent model will be obtained. In Canada and Saudi Arabia, a priori or deferred consent model will be used. In Poland, a waved consent model will be used.
Recruitment Rate
A successful recruitment rate will be defined as achieving enrollment of 40 patients, conventionally expressed as four patients per month over the duration of the trial. While the pilot trial is ongoing, recruitment will be reviewed weekly and the screening records will be reviewed monthly with the cases of missed eligible patients reviewed. If applicable, barriers to enrollment will be addressed to maximize 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.
Protocol Adherence
Successful adherence will be defined as ≥80%. The adherence will be calculated as the proportion of patients that were assigned to the control arm being extubated after CLT being performed and the portion of people that assigned to the intervention arm who are given the prescribed steroids for a failed CLT. As this pilot trial is ongoing, investigators will review adherence monthly and investigate the reasons for compliance failure. All reasons for either failure to extubate after a failed CLT in the control arm will be investigated. The RC will review the Respiratory Therapists' notes, and the medication profile to determine actual compliance. All reasons for non-compliance will be recorded for both groups using distinguishing clinical reasons (eg. Palliation, death, consent withdrawal, errors).

Secondary Outcome Measures

Postextubation stridor
Defined as an audible high pitched inspiratory noise caused by turbulent airflow through the narrowed airway that is detectable with or without a stethoscope within 48 hours of extubation.
Clinically significant postextubation stridor
Defined as stridor (see definition above) that requires medical intervention such as the administration of systemic steroids, racemic epinephrine, or Heli-ox.
Reintubation
Defined as reintubation within 72 hours of original extubation while in the ICU.
Emergency surgical airway
Defined as performing urgent tracheotomy or cricothyroidotomy for a life-threatening airway obstruction
In ICU mortality
In hospital mortality truncated at 30 days
Duration of mechanical ventilation
Defined as time on the ventilator after randomization in days.
ICU length of stay in days

Full Information

First Posted
December 1, 2017
Last Updated
August 23, 2022
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT03372707
Brief Title
Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU
Acronym
COMIC
Official Title
Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 5, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Introduction: Endotracheal intubation and mechanical ventilation are lifesaving interventions that are commonly done in the intensive care unit (ICU). The act of intubating someone can cause laryngeal edema (LE) that, if extensive enough, can cause airway obstruction after a patient is extubated. To date, the only test that is available to predict this complication is the cuff leak test (CLT). However, its diagnostic accuracy is uncertain as there have been no randomized controlled trials (RCT) examining this. The Cuff leak and airway Obstruction in Mechanically ventilated ICU patients (COMIC) Randomized Control Trial will be done to examine the impact of CLT on postextubation stridor and reintubation. Subsequently, describing the diagnostic accuracy of this test. Methods: This will be a multi-center centered, pragmatic, double blinded RCT. Mechanically ventilated patients in the ICU, who are deemed ready to be extubated will be included. All patients will have a CLT done prior to extubation. The results of the CLT in the intervention arm will be communicated to the treating physician, and decision to extubate will be left to the treating team, while the results of the CLT for patients in the control arm will not be communicated to the treating physician, and the patient will be extubated, regardless of the result of the CLT. Objective: This is a pilot trial to assess feasibility of conducting a powered RCT. Feasibility outcomes include: consent rate, recruitment rate, and protocol adherence. Clinical outcomes will include postextubation stridor, reintubation, emergency surgical airway, ICU mortality, in hospital mortality, duration of mechanical ventilation, and ICU length of stay in days.
Detailed Description
INTRODUCTION Endotracheal intubation and mechanical ventilation are lifesaving interventions. However, as with acute interventions, can be associated with serious complications. One such complication is laryngeal edema (LE) that occurs in 4-55% of patients. LE is thought to be caused by marked polymorphonuclear infiltration to the traumatized upper airway postintubation. The incidence of LE increases as the duration of intubation accrues, but it can occur as early as the first 24 hours of intubation. LE can result in airway narrowing and increased airflow velocity. It is postulated that narrowing of the lumen by 50% or more may result in postextubation stridor and respiratory distress. As a result, 3.5% (range 0-10.5%) of patients with LE will fail an extubation attempt and require reintubation. For various reasons, reintubation has a significant morbidity and mortality. Identifying patients with LE can be challenging, the presence of the endotracheal tube (ETT) precludes direct visualization of the upper airway prior to extubation, therefore, clinicians cannot accurately predict airway obstruction before it occurs. A cuff-leak test (CLT) was first described in 1988 as a surrogate for direct visualization and a screening for airway edema prior to extubation. This test involves deflating the balloon cuff on an ETT and observing if the patient is able to breathe around it. If air can pass around the ETT, it suggest that the airway is patent and clinicians may proceed with extubation. A small leak or complete absence of one, would suggest an airway obstruction. There are conflicting results on the utility and accuracy of a CLT. To date, two meta-analyses of observational studies examined the diagnostic accuracy of a CLT. One meta-analysis reports that a failed CLT is insensitive but a specific predictor of LE (pooled sensitivity and specificity 0.56; 95% CI, 0.48-0.63 and 0.92; 95% CI, 0.90-0.93, respectively) and reintubation (pooled sensitivity and specificity for reintubation 0.63; 95% CI, 0.38-0.84 and 0.86; 95% CI, 0.81-0.90, respectively). While the second meta-analysis also states that the failed CLT was associated with postextubation LE, particularly in patients with > 5 days duration of intubation (odds ratio [OR]=2.09; 95% CI, 1.28-2.89), it was not associated with higher odds of reintubation (OR=0.94; 95% CI, 0.32-1.57). Despite the lack of high quality studies, an absent cuff leak usually results in delayed extubation and exposure to corticosteroids to empirically treat airway edema. A recent meta-analysis of 11 parallel randomized controlled trails (RCTs) with a total of 2472 patients examined the effect of prophylactic corticosteroids prior to extubation on postextubation stridor and reintubation. Prophylactic corticosteroids use reduced the risk of postextubation airway events when compared to placebo or no treatment (RR 0.43; 95% CI 0.29-0.66, P=0.002). A subgroup analysis demonstrates that this benefit is only significant in patients that are deemed "high risk" for LE. Prophylactically treating unspecified patients shows no reduction in postextubation events and exposes patients to high dose steroids (16). Moreover, a false positive CLT can unnecessarily delay extubation, leading to a prolonged length of stay in the intensive care unit (ICU), barotraumas, and increased risk of ventilator associated pneumonias, therefore, exposing patients unnecessarily to these undesirable outcomes. On the other hand, if a CLT is not performed, or if in case of a false negative test, some patients may fail the extubation attempt and require reintubation. Recent clinical practice guidelines for using CLT reflect this uncertainty. The American Thoracic Society guidelines on liberation of mechanical ventilation issued a weak recommendation for performing CLT in mechanically ventilated adults who are at high risk for postextubation stridor (conditional recommendation, very low certainty). There is also significant clinical equipoise. A recent unpublished survey found that 42% (12/26) of Canadian intensive care unit (ICU) physicians either never or rarely request to know the results of a cuff leak test prior to extubating a patient that is at moderate risk of laryngeal edema while 23% will always or usually order the test. Therefore, a large RCT is necessary to investigate the diagnostic accuracy of the CLT and its impact on patients' outcomes. Herein, the investigators are reporting the protocol for the COMIC Pilot Trial. The COMIC (Cuff leak and airway Obstruction in Mechanically ventilated ICU patients) pilot trial will be a multicenter, randomized, concealed, blinded, parallel-group, pragmatic pilot trial. The purpose is to determine the feasibility of undertaking a powered RCT to examine the impact of CLT on postextubation stridor and reintubation. Subsequently, describing the diagnostic accuracy of this test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngeal Edema
Keywords
Cuff leak test, Post-extubation airway obstruction, Laryngeal edema

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Patients, Research Coordinators, study investigators, adjudicators, and data analysts will be blinded to the results of CLT in the control group.
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Patients randomized to the intervention arm will have the results of the Cuff Leak Test (CLT) (whether failed or passed) communicated to the treating physician; the treating physician will decide whether to proceed with extubation or not based on the CLT results. It is at the discretion of the treating physician to provide corticosteroids (4-5 mg of intravenous dexamethasone every six hours for up to 24 hours, with the last dose given one hour preceding extubation) and/or delay extubation by 24 hours should the patient fail the CLT.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
In the control arm of this trial; the treating physicians and healthcare workers will be blinded to the results of the Cuff Leak Test (CLT); therefore, the Respiratory Therapist (RT) will proceed with extubation without delay or administering systemic steroid, regardless to the CLT results.
Intervention Type
Diagnostic Test
Intervention Name(s)
Cuff Leak Test
Intervention Description
The Respiratory Therapist (RT) will perform the CLT on all enrolled patients. The patients will first be switched to volume assist-control (V-AC) with a respiratory rate of 10 breaths/min (to allow patient assist), constant flow of 60 l/min, and tidal volume set to match the average tidal volume currently being delivered during supportive ventilation. The RT will document the average exhaled volume over 3-5 breaths after switching to V-AC. The test will be performed by deflating the ETT balloon cuff with a 10 cc syringe, and: a) auscultation with a stethoscope to identify audible air leak around the ETT, and b) measuring the difference between the average exhaled volume prior to cuff deflation and the average exhaled volume over 3-5 breaths after cuff deflation.
Primary Outcome Measure Information:
Title
Consent Rate
Description
A successful consent rate will be defined as 70% of substitute decision makers (SDMs) or patients approached to consent, choosing to participate in the trial. This will be calculated as the overall proportion of SDMs or patients consenting out of those approached (with 95% CI). Note that a mixed consent model will be obtained. In Canada and Saudi Arabia, a priori or deferred consent model will be used. In Poland, a waved consent model will be used.
Time Frame
1 year
Title
Recruitment Rate
Description
A successful recruitment rate will be defined as achieving enrollment of 40 patients, conventionally expressed as four patients per month over the duration of the trial. While the pilot trial is ongoing, recruitment will be reviewed weekly and the screening records will be reviewed monthly with the cases of missed eligible patients reviewed. If applicable, barriers to enrollment will be addressed to maximize 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.
Time Frame
1 year
Title
Protocol Adherence
Description
Successful adherence will be defined as ≥80%. The adherence will be calculated as the proportion of patients that were assigned to the control arm being extubated after CLT being performed and the portion of people that assigned to the intervention arm who are given the prescribed steroids for a failed CLT. As this pilot trial is ongoing, investigators will review adherence monthly and investigate the reasons for compliance failure. All reasons for either failure to extubate after a failed CLT in the control arm will be investigated. The RC will review the Respiratory Therapists' notes, and the medication profile to determine actual compliance. All reasons for non-compliance will be recorded for both groups using distinguishing clinical reasons (eg. Palliation, death, consent withdrawal, errors).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Postextubation stridor
Description
Defined as an audible high pitched inspiratory noise caused by turbulent airflow through the narrowed airway that is detectable with or without a stethoscope within 48 hours of extubation.
Time Frame
48 hours after original extubation
Title
Clinically significant postextubation stridor
Description
Defined as stridor (see definition above) that requires medical intervention such as the administration of systemic steroids, racemic epinephrine, or Heli-ox.
Time Frame
48 hours after original extubation
Title
Reintubation
Description
Defined as reintubation within 72 hours of original extubation while in the ICU.
Time Frame
72 hours after original extubation
Title
Emergency surgical airway
Description
Defined as performing urgent tracheotomy or cricothyroidotomy for a life-threatening airway obstruction
Time Frame
30 days
Title
In ICU mortality
Time Frame
1 year
Title
In hospital mortality truncated at 30 days
Time Frame
30 days
Title
Duration of mechanical ventilation
Description
Defined as time on the ventilator after randomization in days.
Time Frame
1 year
Title
ICU length of stay in days
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eligible patients will be mechanically ventilated adults (>18 years) who are admitted to the ICU and an order to extubate has been provided by the treating physician. Exclusion Criteria: A palliative care, a one-way extubation, or a decision to withdraw advances life support order has been written. Pregnancy. Patients at high risk for LE: burn patients, smoke inhalation injuries (as defined as singed facial hair or nasal hair, carbonaceous secretions/sputum, and known to be in an enclosed fire), blunt or penetrating trauma involving the neck and airway, postoperative head and neck surgeries, and patients admitted with airway edema to the ICU (e.g; anaphylaxis). Patients with either a difficult or traumatic endotracheal intubation. Patients receiving mechanical ventilation via tracheostomy. Known preexisting tracheolaryngeal abnormalities such as: vocal cord paralysis, tracheolaryngeal neoplasm, tracheomalacia, tracheolaryngeal stenosis, or previous head and neck surgeries. Patients receiving systemic corticosteroids of greater than 30 mg of PO prednisone or equivalent, within 4 days prior to the decision to extubate. Patients who failed extubation attempt within the current ICU admission. History of postextubation airway obstruction. The ICU physician declined enrolling the patient. Patient had a failed CLT in the previous 24 hours.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberley A Lewis, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Waleed Alhazzani, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Joseph's Hospital
City
Hamilton
State/Province
Ontartio
ZIP/Postal Code
L8N 46
Country
Canada
Facility Name
Jagiellonian University Medical College
City
Kraków
State/Province
Lesser Poland
ZIP/Postal Code
31-066
Country
Poland
Facility Name
Imam Adbulrahman Bin Faisal University
City
Dammam
State/Province
Eastern Province
ZIP/Postal Code
34212
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
http://www.comictrial.com
Description
COMIC Trial Website

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Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU

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