The Effect of 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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atelectasis
- Sponsor
- Evangelismos Hospital
- Enrollment
- 48
- Primary Endpoint
- Forced Expiratory Volume at One Second (FEV1) Difference
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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) and possible placebo device-related effects (sham-Bi-PAP) were investigated.
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 was applied at individualized pressures in order to optimize respiratory support and sham Bi-PAP was also used in order to neutralize possible placebo device related effect and researcher related bias. The investigators hypothesized that the use of Bi-PAP at individualized pressures in MOP undergoing OBS, ameliorates postoperative respiratory function as well as diminishes related pulmonary complications, postoperative pain and duration of hospitalization. Primary endpoints were the difference in pre- and postoperative measurements of certain pulmonary function parameters (forced expiratory volume at one second (FEV1), forced vital capacity (FVC), peak expiratory flow rate (PEFR) and oxygen saturation by pulse oximetry (SpO2) and the incidence of certain pulmonary complications postoperatively (hypoxemia, atelectasis, lower respiratory tract infections). Secondary endpoints were postoperative pain and days of hospitalization.
Investigators
Alexandropoulou N. Aikaterini
Consultant
Evangelismos Hospital
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.
Outcomes
Primary Outcomes
Forced Expiratory Volume at One Second (FEV1) Difference
Time Frame: 24 h before surgery and at 24, 48 and 72 h post-operatively
difference in FEV1 value measured by spirometry pre- and post-operatively
Forced Vital Capacity (FVC) Difference
Time Frame: 24 h before surgery and at 24, 48 and 72 hours post-operatively
difference in FVC value measured by spirometry pre- and post-operatively
Peak Expiratory Flow Rate (PEFR) Difference
Time Frame: 24 h before surgery and at 24, 48 and 72 hours post-operatively
difference in PEFR value measured by spirometry pre- and post-operatively
SpO2 Difference
Time Frame: 24 h before surgery and at 24, 48 and 72 hours post-operatively
difference in SpO2 value measured by spirometry pre- and post-operatively
Number of Participants With Hypoxemia
Time Frame: At 24, 48 and 72 hours post-operatively
occurrence of hypoxemia, considered as SpO2\<90%, post-operatively
Number of Participants With Atelectasis
Time Frame: At 24, 48 and 72 hours post-operatively
occurrence of atelectasis as defined by chest X-ray (CXR) post-operatively with CXR before surgery as baseline
Secondary Outcomes
- Post-operative Pain(right before spirometry, at 24, 48 and 72 h post-operatively)
- Days of Hospitalization(From day of admission to day of discharge from the hospital)