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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified Cuff Leak Test | Experimental | The subject was placed in a semi-recumbent position. The subjects were placed in volume assist-control mode with the following parameters:
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| Usual Cuff Leak Test | Active Comparator | The subjects were placed in volume assist-control mode with the following parameters:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cuff Leak Test | 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. |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| mortality of 90 days | mortality of 90 days | 90 days |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bing Sun | Beijing | Beijing Municipality | 100020 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39922534 | Derived | Tang X, Gu YM, Shi Y, Li ZM, Cao R, Lu SG, Wu YB, Tao YF, Sun ZY, Yin YJ, Liu CY, Tang XB, Gan GF, Qin XJ, Yin D, Zhao HB, Liu CY, Zhang L, Fang P, Du LS, Li L, Tan H, Li M, Zuo YT, Sun B; Chao-Yang Mechanical Ventilation Study Collaboration Group. Modified Cuff Leak Test for Predicting the Risk of Reintubation in Patients With Invasive Mechanical Ventilation: A Multicenter, Single-Anonymized, Randomized Controlled Trial. Chest. 2025 Jul;168(1):119-130. doi: 10.1016/j.chest.2025.01.033. Epub 2025 Feb 6. |
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| ID | Term |
|---|---|
| D000402 | Airway Obstruction |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| 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 |