Airway Obstruction, Mechanical Ventilation Complication, Weaning Failure
Conditions
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.
Interventions
DIAGNOSTIC_TESTCuff 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.
Sponsors
Beijing Chao Yang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Reintubation within 48 hours after extubation | 48 hours | The incidence of reintubation within 48 hours after extubation in the ICU. |
| Post-extubation stridor | 24 hours | the occurrence of inspiratory stridor within 24 hours following tracheal extubation. |
| Invasive mechanical ventilation time before first extubation | 28 days | Invasive mechanical ventilation time before first extubation |
| length of hospital | 90 days | the length of patient staying in hosptial |
| required reintubation within 48 hours following extubation | 48 hours | The incidence of required reintubation within 48 hours after extubation in the ICU. |
| length of ICU | 90 days | the length of patient staying in intensive care unit |
Other
| Measure | Time frame | Description |
|---|---|---|
| mortality of 90 days | 90 days | mortality of 90 days |
Countries
China
Outcome results
None listed