A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

586 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2024-03-24

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Mechanical Ventilation Complication Weaning Failure Airway Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Cuff Leak Test

Intervention Type DIAGNOSTIC_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.

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.

Group Type ACTIVE_COMPARATOR

Cuff Leak Test

Intervention Type DIAGNOSTIC_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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No