N/A
N=47
Bi-PAP vs Sham Bi-PAP on Pulmonary Function in Morbidly Obese Patients After Bariatric Surgery
Atelectasis · Pulmonary Infection · Chronic Obstructive Pulmonary Disease (COPD) · Pulmonary Disease · Hypoxemic Respiratory Failure
Bottom Line
View on ClinicalTrials.gov: NCT03438383 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Forced Expiratory Volume at One Second (FEV1) Difference — 3.1; 3.1; 1.3; 1.4 Litres — p=0.88
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bi-PAP (Device); Sham Bi-PAP (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Evangelismos Hospital
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Forced Expiratory Volume at One Second (FEV1) Difference |
3.1; 3.1; 1.3; 1.4; 1.3; 1.7 | 0.88 |
| PRIMARY Forced Vital Capacity (FVC) Difference |
3.4; 3.5; 1.3; 1.6; 1.5; 2.0 | 0.75 |
| PRIMARY Peak Expiratory Flow Rate (PEFR) Difference |
376.9; 325.3; 146.9; 137.4; 166.0; 195.7 | 0.05 |
| PRIMARY SpO2 Difference |
96.9; 96.9; 91.6; 92.6; 92.4; 95.2 | 0.83 |
| PRIMARY Number of Participants With Hypoxemia |
5; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Atelectasis |
3; 0; 3; 0; 3; 0 | — |
| SECONDARY Post-operative Pain |
6.5; 6.5; 4.5; 5.3; 3.3; 3.5 | — |
| SECONDARY Days of Hospitalization |
6; 6; 10; 10 | — |
Summary
The effect of biphasic positive airway pressure (Bi-PAP) at individualized pressures on the postoperative pulmonary recovery of morbidly obese patients (MOP) undergoing open bariatric surgery (OBS) and possible placebo device-related effects (sham-Bi-PAP) were investigated.
Eligibility Criteria
Inclusion Criteria
- All patients have been Morbidly Obese (BMI> 40kg/m2) for at least 10 years
- All patients had unsuccessfully tried to lose weight by other non-invasive means.
- All patients enrolled were continuous positive airway pressure (CPAP) and Bi-PAP naïve and had no knowledge about the Bi-PAP apparatus prior to enrollment
- All patients underwent OBS (gastroplasty by Mason or gastric bypass) by the same operating team
- All patients were treated with the same standard anesthetic protocol
Exclusion Criteria
- Cardiovascular and pulmonary disease not related to obesity status
- Chronic renal disease
- Patients who were initially enrolled but did not use the allocated device (Bi-PAP or Sham Bi-PAP) for at least 12 h daily were also excluded at a later point.
Data sourced from ClinicalTrials.gov (NCT03438383). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.