Mechanical Ventilation Complication Clinical Trial
Official title:
A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients: a Multicenter Randomised Controlled Trial
Verified date | March 2024 |
Source | Beijing Chao Yang Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 586 |
Est. completion date | March 24, 2024 |
Est. primary completion date | March 24, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Bing Sun | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Chao Yang Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | mortality of 90 days | mortality of 90 days | 90 days | |
Primary | 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 | Reintubation within 48 hours after extubation | The incidence of reintubation within 48 hours after extubation in the ICU. | 48 hours | |
Secondary | Post-extubation stridor | the occurrence of inspiratory stridor within 24 hours following tracheal extubation. | 24 hours | |
Secondary | Invasive mechanical ventilation time before first extubation | Invasive mechanical ventilation time before first extubation | 28 days | |
Secondary | length of ICU | the length of patient staying in intensive care unit | 90 days | |
Secondary | length of hospital | the length of patient staying in hosptial | 90 days | |
Secondary | required reintubation within 48 hours following extubation | The incidence of required reintubation within 48 hours after extubation in the ICU. | 48 hours |
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