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

Morbid Obesity Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03438383
• Other study ID #: 142/23-05-2011
• Status: Completed
• Phase: N/A
• Start date: May 23, 2011
• Est. completion date: May 31, 2012

Study information

• Verified date: November 2020
• Source: Evangelismos Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 31, 2012
• Est. primary completion date: May 22, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Atelectasis
• Chronic Obstructive Pulmonary Disease (COPD)
• Hypoxemia
• Hypoxemic Respiratory Failure
• Hypoxia
• Lung Diseases
• Lung Diseases, Obstructive
• Morbid Obesity
• Obesity, Morbid
• Pulmonary Atelectasis
• Pulmonary Disease
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Infection
• Respiratory Insufficiency

Intervention

Device:
• Bi-PAP
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.
• Sham Bi-PAP
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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Evangelismos Hospital	Elpis General Hospital, Evgenidion Hospital, Sotiria General Hospital

References & Publications (40)

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* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Number of Participants With Hypoxemia	occurrence of hypoxemia, considered as SpO2<90%, post-operatively	At 24, 48 and 72 hours post-operatively
Primary	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	Post-operative Pain	Intensity of pain was assessed post-operatively by Numerical Rating Scale (NRS) (0-10, 0=no pain, 10=worst pain imaginable)	right before spirometry, at 24, 48 and 72 h post-operatively
Secondary	Days of Hospitalization	duration of hospitalization, calculated by discharge date minus admission date	From day of admission to day of discharge from the hospital

External Links

•   Publication of Study Results