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| Name | Class |
|---|---|
| Hospital Civil de Guadalajara | OTHER |
| Medical College of Wisconsin | OTHER |
| The University of Texas Health Science Center, Houston | OTHER |
| Central DuPage Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group (NIV with HFNC) | Experimental | Patients randomized to the intervention group will receive NIV alternating with HFNC for 24 hours after extubation |
|
| Control Group (HFNC alone) | Active Comparator | Patients randomized to the intervention group will receive HFNC only for 24 hours after extubation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noninvasive ventilation alternating with high flow nasal cannula | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment failure defined by use of rescue respiratory support for acute respiratory failure in the first 72 hours after planned extubation | Rescue respiratory support is defined as reintubation, use of rescue NIV or HFNC use | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Reintubation rate | Need for invasive mechanical ventilation within 7 days of extubation | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ramandeep Kaur, PhD | Contact | 3129478898 | ramandeep_kaur@rush.edu | |
| Babak Mokhlesi, MD | Contact | (312) 563-0843 | babak_mokhlesi@rush.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ramandeep Kaur, PhD | Rush University Medical Center | Principal Investigator |
| Babak Mokhlesi, MD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
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| OTHER |
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| High flow nasal cannula | Device | A total of 24 hours of prophylactic respiratory support will be provided using HFNC alone. |
|
| Central DuPage Hospital | Not yet recruiting | Winfield | Illinois | 60190 | United States |
|
| McGovern Medical School, The University of Texas Health Science Center | Recruiting | Houston | Texas | 77030 | United States |
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| Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
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| Hospital Civil Fray Antonio Alcalde | Recruiting | Guadalajara | Jalisco | 44280 | Mexico |
|
| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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