A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients

Study Overview
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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.

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.

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

Conditions
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Mechanical Ventilation Complication, Weaning Failure, Airway Obstruction

Intervention / Treatment
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* Diagnostic Test: Cuff Leak Test


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified Cuff Leak Test<br>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<br>* 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.<br>|
| Active Comparator: Usual Cuff Leak Test<br>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<br>* 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.<br>|

What is the study measuring?
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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 |