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Clinical Trials/NCT02682771
NCT02682771
Completed
Not Applicable

Effects of Positive Airway Pressure and Incentive With Load Inspiratory on Lung Function and Respiratory Muscle in Post-bariatric Surgery - a Randomized and Blind Clinical Trial

Universidade Metodista de Piracicaba1 site in 1 country60 target enrollmentNovember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Inadequate or Impaired Respiratory Function
Sponsor
Universidade Metodista de Piracicaba
Enrollment
60
Locations
1
Primary Endpoint
Pulmonary function
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Obesity, due to excess fat in the thoracoabdominal region, can promote changes in respiratory function and lung function, leading to reduction in lung volume and capacity. Such dysfunctions are worsen after bariatric surgery to be associated with factors inherent to this procedure. The objective of this study was to evaluate and compare the effects of the application of bilevel positive airway pressure and exercises with inspiratory pressure with linear load in thoracoabdominal mobility, pulmonary function, inspiratory muscle strength, respiratory muscle strength and prevalence of pulmonary complications after bariatric surgery.

Detailed Description

This is a clinical trial, randomized, blinded, in which 60 volunteers, after evaluation preoperatively, consisting of: cirtometry to measure thoracoabdominal mobility, spirometry for measures of lung function, nasal inspiratory pressure to inspiratory muscle strength and endurance incremental test for evaluation of respiratory muscle strength, were randomized and allocated into three groups, with 20 volunteers each. The interventions were performed in the immediate postoperative period and the first day after surgery. The first group, called the control group received care by Conventional Respiratory Physiotherapy (CRP), consisting of breathing exercises, incentive spirometer and ambulation. The second group, called Positive Pressure Group received two-level positive airway pressure for one hour, addition of CRP. The third group, called Load Inspiratory Group held exercises with inspiratory pressure with linear load, linked also to the CRP. Treatments were applied twice in the immediate postoperative period and shortly after returning to the ward and after 4 hours of the initial treatment and three times a day on the first day after surgery. On discharge, the second day after surgery, the volunteers performed chest x-ray and underwent the same evaluations performed preoperatively.

Registry
clinicaltrials.gov
Start Date
November 2014
End Date
December 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Factorial
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eli Maria Pazzianotto Forti

Principal Investigator

Universidade Metodista de Piracicaba

Eligibility Criteria

Inclusion Criteria

  • Submitted to Roux-en-Y type gastric bypass by laparotomy
  • Normal preoperative pulmonary function and chest x-ray

Exclusion Criteria

  • Hemodynamic instability
  • Hospital Stay longer than three days
  • Presence of postoperative complications
  • Respiratory chronic diseases

Outcomes

Primary Outcomes

Pulmonary function

Time Frame: up to 2 days after surgery

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 lumg volumes and flows: slow vital capacity, forced vital capacity and maximum voluntary ventilation. The maneuvers were carried out until three acceptable and reproducible curves were obtained, not exceeding more than eight attemps. 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.

Secondary Outcomes

  • Thoracoabdominal mobility(up to 2 days after surgery)
  • Evaluation of inspiratory muscle endurance(up to 2 days after surgery)
  • Evaluation of muscle strength inspiratory(up to 2 days after surgery)

Study Sites (1)

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