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Effect of Boussignac CPAP Ventilation on PaO2 and PaO2/FiO2 Ratio in Morbidly Obese Patients Undergoing Bariatric Surgery

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Boussignac CPAP
Venturi face mask
Sponsored by
Centro Hospitalar do Porto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients age between 18 and 65 years of age
  • Morbidly obese with a body mass index > 35 kg/m2
  • Laparoscopic gastric bypass

Exclusion Criteria:

  • Patient refusal
  • American Society of Anesthesiologists' (ASA) class IV
  • Lung parenchyma disease
  • Chronic Obstructive Pulmonary Disease
  • Moderate to severe asthma
  • Pre-existing cardiac failure (above class II in the New York Heart Association (NYHA) classification)
  • Estimated pulmonary artery pressure ≥35mmHg
  • Hemoglobin concentration ([Hgb]) less than 7 g / dL
  • Need for invasive ventilation during preoperative immediate post-extubation defined in the preoperative period
  • Patients with obstructive sleep apnea previously treated with CPAP
  • Severe psychiatric disorder
  • Language barrier

Sites / Locations

  • Centro Hospitalar Porto

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Boussignac CPAP

Ventury face mask

Arm Description

Boussignac CPAP with a 50% FiO2 (adjusted in a piece adapted to the system) and a pressure of 5cmH2O (measured with a manometer) is applied immediately after extubation and mantained for two hours after extubation in the post anesthesia care unit (PACU). Arterial blood samples to measure PaO2 and PaO2/FiO2 ratio are collected before surgery and at 1, 2 and 24 hours after extubation. Spirometry is performed at the same intervals measuring FEV1 and FVC.

Venturi mask with a 50% FiO2 is used immediately after extubation and mantained for two hours in the post anesthesia care unit (PACU). Arterial blood samples to measure PaO2 and PaO2/FiO2 ratio are collected before surgery and at 1, 2 and 24 hours after extubation. Spirometry is performed at the same intervals measuring FEV1 and FVC.

Outcomes

Primary Outcome Measures

Difference in mean PaO2 values after surgery
Arterial blood samples for blood gas analysis are collected at 1 hour, 2 hours and 24 hours post-extubation. The differences in the mean values of PaO2 are registered and analysed.
Difference in mean PaO2/FiO2 ratio values after surgery
Arterial blood samples for blood gas analysis are collected at 1 hour, 2 hours and 24 hours post-extubation. The differences in the mean values of PaO2/FiO2 ratio are registered and analysed.

Secondary Outcome Measures

Difference in mean FEV 1 and FVC values
Spirometry is performed at 1 hour, 2 hours and 24 hours post-extubation. The differences in the mean values of FEV1 and FVC are measured and analysed.

Full Information

First Posted
November 17, 2014
Last Updated
April 23, 2015
Sponsor
Centro Hospitalar do Porto
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1. Study Identification

Unique Protocol Identification Number
NCT02297828
Brief Title
Effect of Boussignac CPAP Ventilation on PaO2 and PaO2/FiO2 Ratio in Morbidly Obese Patients Undergoing Bariatric Surgery
Official Title
Effect of Boussignac Continuous Positive Airway Pressure Ventilation on PaO2 and PaO2/FiO2 Ratio Immediately After Extubation in Morbidly Obese Patients Undergoing Bariatric Surgery: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Hospitalar do Porto

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine if the application of Boussignac continuous positive airway pressure (CPAP) immediately after extubation improves PaO2 and PaO2/FiO2 ratio in morbidly obese patients undergoing gastric bypass surgery .
Detailed Description
Background: In 2010, the prevalence of obesity in individuals above 15 years old in Portugal was 15.5% for males and 17.7% for females. .In this country bariatric surgery has increased significantly playing an important role in the treatment of individuals with BMI ≥ 40 kg/m2 or less than 35 kg/m2 in the presence of comorbidities. Morbid obesity has a negative impact in the respiratory physiology and is associated with a decreased compliance of the lung and chest wall, increased airway resistance, decreased respiratory muscle strength, increased work of breathing, worsening of ventilation / perfusion ratio and postoperative hypoxemia. General anesthesia and surgery in these patients will maximize these physiologic alterations. Ahmad et al. (2008) found that morbid obesity per se, regardless of the presence of obstructive sleep apnea was associated with increased risk of desaturation in the first 24h of the postoperative period. Gaszynski et al. (2007) found that the use of Boussignac CPAP in the postoperative period of patients undergoing bariatric surgery improved oxygenation. However, it was used capillary blood gas analysis not arterial blood and the FiO2 was different between groups. More recently, in 2011, Wong et al. investigated the effect of Boussignac CPAP versus Venturi mask in the first one hour after bariatric surgery, measuring the PaO2 / FiO2 ratio at 1 hour and 2 hours of the postoperative period. The group maintained with CPAP showed better results. There were no differences between the two groups for FEV1 and FVC. The study does not reveal, however, the analgesic protocol used postoperatively or the patient's position during the spirometric measurements. These variables could be possible confounders. The PaO2 absolute value was not evaluated because of the different FiO2 between patients. Objectives: We aim to assess the impact of the application of Boussignac CPAP ventilation immediately after extubation for improving PaO2 and PaO2/FiO2 ratio in morbidly obese patients submitted to gastric bypass surgery. As a secondary objective we intend to evaluate if there are differences in spirometry parameters. Methods: A randomized controlled study on 24 patients undergoing gastric bypass surgery. Control group receives a Ventury mask immediately after extubation and the intervention group gets the Boussignac CPAP immediately after extubation. Both groups have the same anesthetic protocol during the intraoperative period and receive a 50% FiO2 after extubation. Venturi mask and Boussignac CPAP are maintained for two hours. A blood sample is collected from radial artery to measure PaO2 and calculate PaO2/FiO2 ratio before surgery and at 1, 2 and 24 hours after extubation in both groups. Evaluation of forced expiraroty volume in 1 second (FEV1) and forced vital capacity (FVC) with a portable spirometer is also performed at the same intervals. Patients are monitored for oxygen saturation, arterial pressure and cardiac rhythm while using the devices. Tolerance to the device, analgesic requirements and sedation level are also monitored and registered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Boussignac CPAP
Arm Type
Experimental
Arm Description
Boussignac CPAP with a 50% FiO2 (adjusted in a piece adapted to the system) and a pressure of 5cmH2O (measured with a manometer) is applied immediately after extubation and mantained for two hours after extubation in the post anesthesia care unit (PACU). Arterial blood samples to measure PaO2 and PaO2/FiO2 ratio are collected before surgery and at 1, 2 and 24 hours after extubation. Spirometry is performed at the same intervals measuring FEV1 and FVC.
Arm Title
Ventury face mask
Arm Type
Active Comparator
Arm Description
Venturi mask with a 50% FiO2 is used immediately after extubation and mantained for two hours in the post anesthesia care unit (PACU). Arterial blood samples to measure PaO2 and PaO2/FiO2 ratio are collected before surgery and at 1, 2 and 24 hours after extubation. Spirometry is performed at the same intervals measuring FEV1 and FVC.
Intervention Type
Device
Intervention Name(s)
Boussignac CPAP
Intervention Description
Boussignac CPAP with a 50% FiO2 (adjusted in a piece adapted to the system) and a pressure of 5cmH2O (measured with a manometer) is applied immediately after extubation and mantained for two hours after extubation in the post anesthesia care unit (PACU).
Intervention Type
Device
Intervention Name(s)
Venturi face mask
Intervention Description
Venturi mask with a 50% FiO2 is used immediately after extubation and mantained for two hours in the post anesthesia care unit (PACU).
Primary Outcome Measure Information:
Title
Difference in mean PaO2 values after surgery
Description
Arterial blood samples for blood gas analysis are collected at 1 hour, 2 hours and 24 hours post-extubation. The differences in the mean values of PaO2 are registered and analysed.
Time Frame
24 hours
Title
Difference in mean PaO2/FiO2 ratio values after surgery
Description
Arterial blood samples for blood gas analysis are collected at 1 hour, 2 hours and 24 hours post-extubation. The differences in the mean values of PaO2/FiO2 ratio are registered and analysed.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Difference in mean FEV 1 and FVC values
Description
Spirometry is performed at 1 hour, 2 hours and 24 hours post-extubation. The differences in the mean values of FEV1 and FVC are measured and analysed.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients age between 18 and 65 years of age Morbidly obese with a body mass index > 35 kg/m2 Laparoscopic gastric bypass Exclusion Criteria: Patient refusal American Society of Anesthesiologists' (ASA) class IV Lung parenchyma disease Chronic Obstructive Pulmonary Disease Moderate to severe asthma Pre-existing cardiac failure (above class II in the New York Heart Association (NYHA) classification) Estimated pulmonary artery pressure ≥35mmHg Hemoglobin concentration ([Hgb]) less than 7 g / dL Need for invasive ventilation during preoperative immediate post-extubation defined in the preoperative period Patients with obstructive sleep apnea previously treated with CPAP Severe psychiatric disorder Language barrier
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joana Guimarães, MD
Organizational Affiliation
Centro Hospitalar do Porto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Hospitalar Porto
City
Oporto
ZIP/Postal Code
4099-001
Country
Portugal

12. IPD Sharing Statement

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