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A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients

Primary Purpose

Mechanical Ventilation Complication, Weaning Failure, Airway Obstruction

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cuff Leak Test
Sponsored by
Beijing Chao Yang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mechanical Ventilation Complication

Eligibility Criteria

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

Inclusion Criteria:

  • Age ≥ 18 years old
  • Oral endotracheal intubation and mechanical ventilation > 36 hours
  • Fulfilled the weaning criteria

Exclusion Criteria:

  • The patient has a chest drainage tube and there is persistent air leak
  • Abnormalities of the larynx: such as tumors or vocal cord paralysis
  • The patient cannot maintain the semi-recumbent position
  • Unconventional weaning, such as awake ECMO, etc
  • Participated in the study during the hospitalization
  • Patients or their relatives refused written informed consent

Sites / Locations

  • Bing SunRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Modified Cuff Leak Test

Usual Cuff Leak Test

Arm Description

The subject was placed in a semi-recumbent position. The subjects were placed in volume assist-control mode with the following parameters: respiratory rate 15 breaths/min original oxygen concentration PEEP 0 cm H2O the VT was set according to the subject's stable VT in the previous ventilator mode inspiratory flow was set at 30 L/min with square waveform Positive cutoff value of the air leak volume was 116 mL and the air leak ratio was 0.32.

The subjects were placed in volume assist-control mode with the following parameters: respiratory rate was adapted to patient comfort original oxygen concentration and PEEP the VT about 8ml/Kg IBW inspiratory flow was set at 60 L/min with square waveform Positive cutoff value of the air leak volume was 110 mL and the air leak ratio was 0.15.

Outcomes

Primary Outcome Measures

fulfilled predefined criteria indicating the need for reintubation within 48 hours following extubation
The incidence of fulfilled predefined criteria indicating the need for reintubation within 48 hours following extubation

Secondary Outcome Measures

Reintubation within 48 hours after extubation
The incidence of reintubation within 48 hours after extubation in the ICU.
Post-extubation stridor
the occurrence of inspiratory stridor within 24 hours following tracheal extubation.
Invasive mechanical ventilation time before first extubation
Invasive mechanical ventilation time before first extubation
length of ICU
the length of patient staying in intensive care unit
length of hospital
the length of patient staying in hosptial
required reintubation within 48 hours following extubation
The incidence of required reintubation within 48 hours after extubation in the ICU.

Full Information

First Posted
September 19, 2022
Last Updated
November 14, 2022
Sponsor
Beijing Chao Yang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05550220
Brief Title
A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients
Official Title
A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients: a Multicenter Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chao Yang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
We hypothesized that the accuracy of the modified cuff leak test in predicting re-intubation in tracheal intubated patients is better than that of the conventional balloon leak test, thereby further reducing the re-intubation rate.
Detailed Description
The cuff leak test is an effective method for predicting the occurrence of upper airway obstruction in patients with endotracheal intubation after extubation, with high specificity and moderate sensitivity. However, there is still no clear and unified cuff leak test operation specification. A cohort study has proposed a modified method. When the patient is placed in a semi-recumbent position of 60 degrees and the ventilator is set to a low-flow square wave, it is more predictive than conventional methods. We hypothesized that the accuracy of the modified cuff leak test in predicting re-intubation in tracheal intubated patients is better than that of the conventional balloon leak test, thereby further reducing the re-intubation rate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Ventilation Complication, Weaning Failure, Airway Obstruction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Modified Cuff Leak Test
Arm Type
Experimental
Arm Description
The subject was placed in a semi-recumbent position. The subjects were placed in volume assist-control mode with the following parameters: respiratory rate 15 breaths/min original oxygen concentration PEEP 0 cm H2O the VT was set according to the subject's stable VT in the previous ventilator mode inspiratory flow was set at 30 L/min with square waveform Positive cutoff value of the air leak volume was 116 mL and the air leak ratio was 0.32.
Arm Title
Usual Cuff Leak Test
Arm Type
Active Comparator
Arm Description
The subjects were placed in volume assist-control mode with the following parameters: respiratory rate was adapted to patient comfort original oxygen concentration and PEEP the VT about 8ml/Kg IBW inspiratory flow was set at 60 L/min with square waveform Positive cutoff value of the air leak volume was 110 mL and the air leak ratio was 0.15.
Intervention Type
Diagnostic Test
Intervention Name(s)
Cuff Leak Test
Intervention Description
Cuff leak test is a simple and convenient tool that can be used to predict upper-airway obstruction after extubation. The CLT is used to assess airway patency through listening for an air leak and observing changes in tidal volume (VT) after the cuff is deflated.
Primary Outcome Measure Information:
Title
fulfilled predefined criteria indicating the need for reintubation within 48 hours following extubation
Description
The incidence of fulfilled predefined criteria indicating the need for reintubation within 48 hours following extubation
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Reintubation within 48 hours after extubation
Description
The incidence of reintubation within 48 hours after extubation in the ICU.
Time Frame
48 hours
Title
Post-extubation stridor
Description
the occurrence of inspiratory stridor within 24 hours following tracheal extubation.
Time Frame
24 hours
Title
Invasive mechanical ventilation time before first extubation
Description
Invasive mechanical ventilation time before first extubation
Time Frame
28 days
Title
length of ICU
Description
the length of patient staying in intensive care unit
Time Frame
90 days
Title
length of hospital
Description
the length of patient staying in hosptial
Time Frame
90 days
Title
required reintubation within 48 hours following extubation
Description
The incidence of required reintubation within 48 hours after extubation in the ICU.
Time Frame
48 hours
Other Pre-specified Outcome Measures:
Title
mortality of 90 days
Description
mortality of 90 days
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years old Oral endotracheal intubation and mechanical ventilation > 36 hours Fulfilled the weaning criteria Exclusion Criteria: The patient has a chest drainage tube and there is persistent air leak Abnormalities of the larynx: such as tumors or vocal cord paralysis The patient cannot maintain the semi-recumbent position Unconventional weaning, such as awake ECMO, etc Participated in the study during the hospitalization Patients or their relatives refused written informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bing Sun, MD
Phone
+8613911151075
Email
ricusunbing@126.com
Facility Information:
Facility Name
Bing Sun
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bing Sun, MD
Phone
+8613911151075
Email
ricusunbing@126.com

12. IPD Sharing Statement

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A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients

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