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Use of Positive Pressure in Morbidly Obese Patients Undergoing Reduction Stomach Surgery

Primary Purpose

Pulmonary Atelectasis, Respiratory Tract Diseases, Pathological Conditions, Signs and Symptoms

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Positive pressure
Sponsored by
Universidade Metodista de Piracicaba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Atelectasis focused on measuring Morbid obesity, Bariatric Surgery, Pulmonary Atelectasis, Spirometry, Continuous Positive Airway Pressure, Physical Therapy Specialty

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI between 40 and 55 kg/m2
  • Aged between 25 and 55 years
  • Submitted to Roux-en-Y type gastric bypass by laparotomy
  • Normal preoperative pulmonary function test

Exclusion Criteria:

  • Hemodynamic instability
  • Hospital stay longer than three days
  • Presence of postoperative complications

Sites / Locations

  • Universidade Metodista de Piracicaba (UNIMEP)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Positive pressure before surgery

Positive pressure during the surgery

Positive pressure after surgery

Control

Arm Description

Subjects treated with positive pressure in the BiPAP mode (Bi-Level Positive Airway Pressure) for one hour before bariatric surgery.

Individuals treated with 10 cm H2O of PEEP (Positive End Expiratory Pressure) during the surgical procedure.

Subjects treated with positive pressure in the BiPAP mode (Bi-Level Positive Airway Pressure) for one hour after bariatric surgery.

Individuals treated with conventional physiotherapy according to the routine service of physiotherapy of the hospital.

Outcomes

Primary Outcome Measures

Pulmonary function
Spirometry was carried out according to the guidelines of the American Thoracic Society (ATS) and European Respiratory Society (ERS) (2005). Three types of maneuver were used in order to evaluate the lung volumes and flows: Slow Vital Capacity (SVC), Forced Vital Capacity (FVC) and Maximum Voluntary Ventilation (MVV). The maneuvers were carried out until three acceptable and reproducible curves were obtained, not exceeding more than eight attempts. The values extracted from each maneuver were selected according to Pereira (2002), and the predicted values calculated using the equation proposed by Pereira et al. (1992) for Brazilians.
Prevalence of atelectasis
The radiological report on the inspiration radiography, issued by the hospital radiologist, was used to analyze the presence of atelectasis.
Thoracoabdominal mobility
The measurement of thoracoabdominal mobility was performed by using a tape scaled in centimeters. In the standing position, the measurements were made at levels axillary, xiphoid and abdominal during rest, and at maximal inspiration and maximal expiration. At each level, the measurements were performed three times. It computed the highest value of inspiration and the lowest of expiration. The absolute difference between these values was considered the thoracoabdominal mobility.
Diaphragmatic mobility
The chest X-ray was made using two radiographic exposures, with the patient in the standing position. The first was taken at the end of a maximal inspiration, seeking the largest inspired lung volume (Total Lung Capacity - TLC), and the second in profound exhalation without changing the position of the film or the patient, seeking the maximum emptying of the lungs (Residual Volume - RV). The diaphragmatic motion was analyzed by superimposing the two radiological films, and calculating the distance between the highest point of the diaphragm in expiration and the highest point of the dome on bilateral inspiration.

Secondary Outcome Measures

Full Information

First Posted
January 31, 2013
Last Updated
February 7, 2013
Sponsor
Universidade Metodista de Piracicaba
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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1. Study Identification

Unique Protocol Identification Number
NCT01786681
Brief Title
Use of Positive Pressure in Morbidly Obese Patients Undergoing Reduction Stomach Surgery
Official Title
Use of Positive Pressure in Morbidly Obese Patients Undergoing Gastroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Metodista de Piracicaba
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

4. Oversight

5. Study Description

Brief Summary
The aim of this study was to investigate the effects of using positive pressure in the preoperative, intraoperative and postoperative morbidly obese individuals undergoing gastroplasty. It is believed that the application of these devices before, during or after surgery can help to improve the lungs and reduce pulmonary complications after surgery to reduce the stomach.
Detailed Description
The aim of this study was to investigate the effects of using positive pressure in the preoperative, intraoperative and postoperative morbidly obese individuals undergoing Roux-en-Y gastric bypass with regard to: lung volumes and capacities, the prevalence of atelectasis, duration of surgery and diaphragmatic mobility. Individuals with BMI between 40 and 55 kg/m2, aged between 25 and 55 years, were submitted to Roux-en-Y type gastric bypass by laparotomy. Patients showing a normal preoperative pulmonary function test were included, but those with hemodynamic instability, a hospital stay longer than three days or the presence of postoperative complications were excluded. The volunteers were divided into four different groups: Gpre: subjects treated with positive pressure in the BiPAP mode (Bi-Level Positive Airway Pressure) for one hour before surgery; Gpos: individuals treated with positive airway pressure (BiPAP) for one hour after surgery; Gpeep: individuals treated with 10 cm H2O of PEEP (Positive End Expiratory Pressure) during the surgical procedure. Gcont: individuals treated with conventional physiotherapy (CP) according to the routine service of physiotherapy of the hospital, including the techniques of pulmonary re-expansion, breathing exercises (deep breaths or fractional), the use of incentive spirometry (Respiron®), bronchial hygiene resources if necessary (Flutter® and cough active or assisted) and assisted ambulation. It should be noted that the physiotherapist was blinded to the individual's participation in the groups, and all patients received conventional physiotherapy, independent of the group in which they were included. The respiratory evaluation (preoperative and second postoperative days) consisted of collecting the anthropometric data, a pulmonary function test and a chest radiography (inspired and expired).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Atelectasis, Respiratory Tract Diseases, Pathological Conditions, Signs and Symptoms
Keywords
Morbid obesity, Bariatric Surgery, Pulmonary Atelectasis, Spirometry, Continuous Positive Airway Pressure, Physical Therapy Specialty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positive pressure before surgery
Arm Type
Experimental
Arm Description
Subjects treated with positive pressure in the BiPAP mode (Bi-Level Positive Airway Pressure) for one hour before bariatric surgery.
Arm Title
Positive pressure during the surgery
Arm Type
Experimental
Arm Description
Individuals treated with 10 cm H2O of PEEP (Positive End Expiratory Pressure) during the surgical procedure.
Arm Title
Positive pressure after surgery
Arm Type
Experimental
Arm Description
Subjects treated with positive pressure in the BiPAP mode (Bi-Level Positive Airway Pressure) for one hour after bariatric surgery.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Individuals treated with conventional physiotherapy according to the routine service of physiotherapy of the hospital.
Intervention Type
Procedure
Intervention Name(s)
Positive pressure
Primary Outcome Measure Information:
Title
Pulmonary function
Description
Spirometry was carried out according to the guidelines of the American Thoracic Society (ATS) and European Respiratory Society (ERS) (2005). Three types of maneuver were used in order to evaluate the lung volumes and flows: Slow Vital Capacity (SVC), Forced Vital Capacity (FVC) and Maximum Voluntary Ventilation (MVV). The maneuvers were carried out until three acceptable and reproducible curves were obtained, not exceeding more than eight attempts. The values extracted from each maneuver were selected according to Pereira (2002), and the predicted values calculated using the equation proposed by Pereira et al. (1992) for Brazilians.
Time Frame
2 days after surgery
Title
Prevalence of atelectasis
Description
The radiological report on the inspiration radiography, issued by the hospital radiologist, was used to analyze the presence of atelectasis.
Time Frame
2 days after surgery
Title
Thoracoabdominal mobility
Description
The measurement of thoracoabdominal mobility was performed by using a tape scaled in centimeters. In the standing position, the measurements were made at levels axillary, xiphoid and abdominal during rest, and at maximal inspiration and maximal expiration. At each level, the measurements were performed three times. It computed the highest value of inspiration and the lowest of expiration. The absolute difference between these values was considered the thoracoabdominal mobility.
Time Frame
2 days after surgery
Title
Diaphragmatic mobility
Description
The chest X-ray was made using two radiographic exposures, with the patient in the standing position. The first was taken at the end of a maximal inspiration, seeking the largest inspired lung volume (Total Lung Capacity - TLC), and the second in profound exhalation without changing the position of the film or the patient, seeking the maximum emptying of the lungs (Residual Volume - RV). The diaphragmatic motion was analyzed by superimposing the two radiological films, and calculating the distance between the highest point of the diaphragm in expiration and the highest point of the dome on bilateral inspiration.
Time Frame
2 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI between 40 and 55 kg/m2 Aged between 25 and 55 years Submitted to Roux-en-Y type gastric bypass by laparotomy Normal preoperative pulmonary function test Exclusion Criteria: Hemodynamic instability Hospital stay longer than three days Presence of postoperative complications
Facility Information:
Facility Name
Universidade Metodista de Piracicaba (UNIMEP)
City
Piracicaba
State/Province
São Paulo
Country
Brazil

12. IPD Sharing Statement

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Use of Positive Pressure in Morbidly Obese Patients Undergoing Reduction Stomach Surgery

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