Noninvasive ventilation alternating with high flow nasal cannula
DeviceA total of 24 hours of prophylactic respiratory support will be provided using NIV alternating with HFNC with total NIV usage of 16 hours and HFNC usage of 8 hours.
NCT Number: NCT05918575
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Hospital Civil Fray Antonio Alcalde, Guadalajara, Jalisco, Mexico
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 patient's 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A total of 24 hours of prophylactic respiratory support will be provided using NIV alternating with HFNC with total NIV usage of 16 hours and HFNC usage of 8 hours.
A total of 24 hours of prophylactic respiratory support will be provided using HFNC alone.
Time frame: 72 hours
Rescue respiratory support is defined as reintubation, use of rescue NIV or HFNC use
Time frame: 7 days
Need for invasive mechanical ventilation within 7 days of extubation
Contact information is provided by the study sponsor or research team.
Babak Mokhlesi, MD
CONTACT
Ramandeep Kaur, PhD
CONTACT
Rush University Medical Center
Other
A Randomized Controlled Trial of Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients
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