Status:
COMPLETED
Bi-PAP vs Sham Bi-PAP on Pulmonary Function in Morbidly Obese Patients After Bariatric Surgery
Lead Sponsor:
Evangelismos Hospital
Collaborating Sponsors:
Elpis General Hospital
Sotiria General Hospital
Conditions:
Atelectasis
Pulmonary Infection
Eligibility:
All Genders
Phase:
NA
Brief 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) an...
Detailed Description
In the present study the effect of Bi-PAP on the postoperative respiratory function and related complications of MOP undergoing OBS through a randomized sham-controlled design was investigated. Bi-PAP...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 23 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2012
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03438383
Start Date
May 23 2011
End Date
May 31 2012
Last Update
December 16 2020
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