Bi-PAP vs Sham Bi-PAP on Pulmonary Function in Morbidly Obese Patients After Bariatric Surgery

NCT03438383 | Completed Results FDA Device

• 1 other identifier: 142/23-05-2011
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (6)

• Forced Expiratory Volume at One Second (FEV1) Difference

  difference in FEV1 value measured by spirometry pre- and post-operatively

  24 h before surgery and at 24, 48 and 72 h post-operatively

• Forced Vital Capacity (FVC) Difference

  difference in FVC value measured by spirometry pre- and post-operatively

  24 h before surgery and at 24, 48 and 72 hours post-operatively

• Peak Expiratory Flow Rate (PEFR) Difference

  difference in PEFR value measured by spirometry pre- and post-operatively

  24 h before surgery and at 24, 48 and 72 hours post-operatively

• SpO2 Difference

  difference in SpO2 value measured by spirometry pre- and post-operatively

  24 h before surgery and at 24, 48 and 72 hours post-operatively

• Number of Participants With Hypoxemia

  occurrence of hypoxemia, considered as SpO2\<90%, post-operatively

  At 24, 48 and 72 hours post-operatively

• Number of Participants With Atelectasis

  occurrence of atelectasis as defined by chest X-ray (CXR) post-operatively with CXR before surgery as baseline

  At 24, 48 and 72 hours post-operatively

Secondary Outcomes (2)

• 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

Study Arms (2)

Sham Bi-PAP

SHAM COMPARATOR

Sham Bi-PAP was applied through nasal mask for 3 days postoperatively. Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of Bi-PAP. With this modality, also used on previous studies, the applied pressure by sham Bi-PAP was constant and equal to 2 centimeter of water (cm H2O).

Device: Sham Bi-PAP

Bi-PAP

ACTIVE COMPARATOR

Bi-PAP through nasal mask, at individualized IPAP/EPAP pressures, was applied for 3 days postoperatively. IPAP and EPAP in the Bi-PAP system were individualized for each patient in accordance with accepted values of SpO2, PaCO2, and patient synchronization and tolerability with the device.Individualized setting of pressures in patient group was applied gradually starting with 12/4 cm H2O (IPAP/EPAP) and up to 18/10 (IPAP/EPAP) with consecutive increases of 2 cm H2O.

Device: Bi-PAP

Interventions

Bi-PAP DEVICE

The Bi-PAP system combines inspiratory support-IPAP (inspiratory positive airway pressure) with expiratory support-EPAP (expiratory positive airway pressure) and has been used, with good results, in a number of different clinical conditions such as COPD, respiratory failure due to neuromuscular disease, cardiogenic pulmonary edema and immediately post-operatively with pro-phylactic purpose.

Bi-PAP

Sham Bi-PAP DEVICE

Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of the conventional Bi-PAP system. By doing so, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.

Sham Bi-PAP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Evangelismos Hospital: lead
• Elpis General Hospital: collaborator
• Sotiria General Hospital: collaborator
• Evgenidion Hospital: collaborator

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  PMID: 31268268 RESULT

Related Links

• Publication of Study Results

MeSH Terms

Conditions

Pulmonary Atelectasis; Pulmonary Disease, Chronic Obstructive; Lung Diseases; Respiratory Insufficiency; Hypoxia; Obesity, Morbid; Postoperative Complications

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Limitations and Caveats

The small sample size in both groups, although calculated to provide adequate statistical power; low tolerance of the Bi-PAP device, which led to the exclusion of some subjects from the study.

Results Point of Contact

• Title: Dr. Konstantinos Roditis, Study Chair
• Organization: Department of Vascular Surgery, Korgialeneio-Benakeio Hellenic Red Cross Hospital, Athens, Greece

roditis.k@gmail.com

+306976686951

Study Officials

• Konstantinos Louis, MD, PhD

  Dpt of ObGyn, Konstantopoulio-Patision Hospital, Greece

  STUDY DIRECTOR

• Konstantinos Roditis, MD, MSc

  Dpt of Vascular Surgery, Korgialenio-Benakio HRC Hospital, Greece

  STUDY CHAIR

• Aikaterini N. Alexandropoulou, MD, PhD

  Anaesthesiology Dpt, Evangelismos Hospital, Greece

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Model Details: 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).

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 19, 2018
• Study Start: May 23, 2011
• Primary Completion: May 22, 2012
• Study Completion: May 31, 2012
• Last Updated: December 16, 2020
• Results First Posted: March 19, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share