Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05918575
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2023-06-15
Brief Title:
Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients
Sponsor:
Rush University Medical Center
Organization:
Rush University Medical Center
Study Overview
Official Title:
A Randomized Controlled Trial of Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Around 20 of the obese patients with higher body mass index BMI who are taken off the breathing tube and breathing machine ventilator end up needing it back to support breathing The re-application of breathing tube is associated with poor outcomes including high risk of pneumonia longer hospital stays and death The purpose of this study is to assess if prophylactic use of noninvasive breathing support after removing the breathing tube lowers the chance of needing the breathing tube again
Detailed Description:
Patients with obesity are at risk of developing respiratory failure due to reduced lung volumes and chest wall compliance Obesity is one of the easily identifiable contributing factors of extubation failure that often leads to prolonged mechanical ventilation use and ICU stay The early application of noninvasive respiratory support especially NIV has been shown to reduce reintubation rates in obese patients in a small non-randomized study However prolonged use of NIV is often associated with decreased patient compliance and increased incidence of skin breakdown HFNC is a noninvasive strategy that is comfortable uses a nasal cannula and provides a high flow rate to meet the patients inspiratory flow demand and thereby reduce work of breathing
The purpose of this RCT will be to determine the effects of using NIV alternating with HFNC for reducing the treatment failure rate compared with HFNC alone in extubated patients with severe obesity We hypothesize that early prophylactic use of NIV alternating with HFNC will decrease the risk of respiratory failure treatment failure in severely obese patients
The purpose of this RCT will be to determine the effects of using NIV alternating with HFNC for reducing the treatment failure rate compared with HFNC alone in extubated patients with severe obesity We hypothesize that early prophylactic use of NIV alternating with HFNC will decrease the risk of respiratory failure treatment failure in severely obese patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None