A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients
- Conditions
- Airway ObstructionMechanical Ventilation ComplicationWeaning Failure
- Interventions
- Diagnostic Test: Cuff Leak Test
- Registration Number
- NCT05550220
- Lead Sponsor
- Beijing Chao Yang Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 586
- Age ≥ 18 years old
- Oral endotracheal intubation and mechanical ventilation > 36 hours
- Fulfilled the weaning 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Modified Cuff Leak Test 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. Usual Cuff Leak Test 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.
- Primary Outcome Measures
Name Time Method fulfilled predefined criteria indicating the need for reintubation within 48 hours following extubation 48 hours The incidence of fulfilled predefined criteria indicating the need for reintubation within 48 hours following extubation
- Secondary Outcome Measures
Name Time Method length of hospital 90 days the length of patient staying in hosptial
length of ICU 90 days the length of patient staying in intensive care unit
Invasive mechanical ventilation time before first extubation 28 days Invasive mechanical ventilation time before first extubation
Post-extubation stridor 24 hours the occurrence of inspiratory stridor within 24 hours following tracheal extubation.
Reintubation within 48 hours after extubation 48 hours The incidence of reintubation within 48 hours after extubation in the ICU.
required reintubation within 48 hours following extubation 48 hours The incidence of required reintubation within 48 hours after extubation in the ICU.
Trial Locations
- Locations (1)
Bing Sun
🇨🇳Beijing, Beijing, China