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

NCT01786681 | Completed

• 1 other identifier: Leticia2011
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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.

  2 days after surgery

• Prevalence of atelectasis

  The radiological report on the inspiration radiography, issued by the hospital radiologist, was used to analyze the presence of atelectasis.

  2 days after surgery

• 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.

  2 days after surgery

• 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.

  2 days after surgery

Study Arms (4)

Positive pressure before surgery

EXPERIMENTAL

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

Procedure: Positive pressure

Positive pressure during the surgery

EXPERIMENTAL

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

Procedure: Positive pressure

Positive pressure after surgery

EXPERIMENTAL

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

Procedure: Positive pressure

Control

NO INTERVENTION

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

Interventions

Positive pressure PROCEDURE

Positive pressure after surgery; Positive pressure before surgery; Positive pressure during the surgery

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Metodista de Piracicaba: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

Universidade Metodista de Piracicaba (UNIMEP)

Piracicaba, São Paulo, Brazil

Location

MeSH Terms

Conditions

Pulmonary Atelectasis; Respiratory Tract Diseases; Pathological Conditions, Signs and Symptoms; Obesity, Morbid

Condition Hierarchy (Ancestors)

Lung Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: February 8, 2013
• Study Start: August 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 8, 2013

Record last verified: 2013-02

Locations

BR (1)