Clinical trial NCT03438383: Bi-PAP vs Sham Bi-PAP on Pulmonary Function in Morbidly Obese Patients After Bariatric Surgery
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atelectasis
Pulmonary Infection
Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease
Hypoxemic Respiratory Failure
Hypoxemia
Morbid Obesity
Keywords: Bi-PAP
BiPAP
morbid obesity
anesthesia
bariatric surgery
sham Bi-PAP
sham BiPAP
postoperative complications
Lead sponsor: Evangelismos Hospital
Sponsor class: OTHER
Collaborators: name: Elpis General Hospital
name: Sotiria General Hospital
name: Evgenidion Hospital
First posted: 2018-02-19
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were assigned into the following two study groups postoperatively:

1. Sham Bi-PAP (control group) group in which sham Bi-PAP was applied through nasal mask for 3 days postoperatively.
2. Bi-PAP group in which Bi-PAP through nasal mask, at individualized IPAP/EPAP pressures, was applied for 3 days postoperatively.

1 patient was initially enrolled in the protocol but was excluded from the participant flow design because of recent onset of cardiovascular disease (CAD).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Forced Expiratory Volume at One Second (FEV1) Difference
timeFrame: 24 h before surgery and at 24, 48 and 72 h post-operatively
measure: Forced Vital Capacity (FVC) Difference
timeFrame: 24 h before surgery and at 24, 48 and 72 hours post-operatively
measure: Peak Expiratory Flow Rate (PEFR) Difference
timeFrame: 24 h before surgery and at 24, 48 and 72 hours post-operatively
measure: SpO2 Difference
timeFrame: 24 h before surgery and at 24, 48 and 72 hours post-operatively
measure: Number of Participants With Hypoxemia
timeFrame: At 24, 48 and 72 hours post-operatively
measure: Number of Participants With Atelectasis
timeFrame: At 24, 48 and 72 hours post-operatively
Secondary outcomes:
measure: Post-operative Pain
timeFrame: right before spirometry, at 24, 48 and 72 h post-operatively
measure: Days of Hospitalization
timeFrame: From day of admission to day of discharge from the hospital
Other outcomes:
Locations:
Study officials:
affiliation: Dpt of ObGyn, Konstantopoulio-Patision Hospital, Greece
name: Konstantinos Louis, MD, PhD
role: STUDY_DIRECTOR
affiliation: Dpt of Vascular Surgery, Korgialenio-Benakio HRC Hospital, Greece
name: Konstantinos Roditis, MD, MSc
role: STUDY_CHAIR
affiliation: Anaesthesiology Dpt, Evangelismos Hospital, Greece
name: Aikaterini N. Alexandropoulou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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