A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients

A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients: a Multicenter Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Airway Obstruction; Mechanical Ventilation Complication; Weaning Failure
• Intervention / Treatment: Diagnostic test: Cuff Leak Test

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.

• Study Type: Interventional
• Enrollment (Actual): 586
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100020
      • Bing Sun

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified Cuff Leak Test; 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.	Diagnostic test: Cuff Leak Test; 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.
Active Comparator: Usual Cuff Leak Test; 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.	Diagnostic test: Cuff Leak Test; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reintubation within 48 hours after extubation	The incidence of reintubation within 48 hours after extubation in the ICU.	48 hours
Post-extubation stridor	the occurrence of inspiratory stridor within 24 hours following tracheal extubation.	24 hours
Invasive mechanical ventilation time before first extubation	Invasive mechanical ventilation time before first extubation	28 days
length of ICU	the length of patient staying in intensive care unit	90 days
length of hospital	the length of patient staying in hosptial	90 days
required reintubation within 48 hours following extubation	The incidence of required reintubation within 48 hours after extubation in the ICU.	48 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality of 90 days	mortality of 90 days	90 days

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): March 24, 2024
• Study Completion (Actual): March 24, 2024

Study Registration Dates

• First Submitted: September 19, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 24, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Airway Obstruction
• Other Study ID Numbers: modified CLT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No