A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients

Capital Medical University

Status: Completed

Conditions: Weaning Failure; Mechanical Ventilation Complication; Airway Obstruction

Treatments: Diagnostic Test: Cuff Leak Test

Study type: Interventional

Funder types: Other

Identifiers

NCT05550220

modified CLT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 586 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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586 participants in 2 patient groups

Modified Cuff Leak Test

Experimental group

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.

Treatment:

Diagnostic Test: Cuff Leak Test

Usual Cuff Leak Test

Active Comparator group

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.

Treatment:

Diagnostic Test: Cuff Leak Test