Positive Airway Pressure Versus Breathing Exercises With Load Inspiratory in Patients Undergoing Bariatric Surgery

NCT02682771 | Completed DMC

• 1 other identifier: UMetodistaPiracicaba
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Inadequate or Impaired Respiratory Function

Keywords

gastroplasty, breathing exercices, positive pressure

Outcome Measures

Primary Outcomes (1)

• 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 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.

  up to 2 days after surgery

Secondary Outcomes (3)

• 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 Arms (3)

Control

ACTIVE COMPARATOR

Individuals were treated with Conventional Respiratory Physiotherapy (CRP), twice in immediate postoperative day and three times in first postoperative day.

Procedure: Conventional Respiratory Physiotherapy (CRP)

Bilevel positive airway pressure

EXPERIMENTAL

Individuals were treated with positive pressure, in the BIPAP mode (bilevel positive airway pressure, with inspiratory pressure:12 cmH20 and expiratory pressure: 8 cmH20) twice in the immediate postoperative day and three times in first postoperative day, in sessions 1 hour each

Device: Bilevel positive airway pressure; Procedure: Conventional Respiratory Physiotherapy (CRP)

Load inspiratory breathing exercises

EXPERIMENTAL

Individuals were treat with PowerBreathe, a device for inspiratory muscle, with 40% maximal inspiratory pressure, measured at preoperative, twice in the immediate postoperative day and three times in first postoperative day, in sessions 1 hour each.

Device: PowerBreathe; Procedure: Conventional Respiratory Physiotherapy (CRP)

Interventions

Bilevel positive airway pressure DEVICE

The use of positive airway pressure airway seeking in the prevention or treatment of hypoxic respiratory failure, improved arterial oxygenation, restoration or maintenance of lung volume reduction and atelectasis, decrease the work of breathing, decreased dyspnea index and increased residual volume

Bilevel positive airway pressure

PowerBreathe DEVICE

Exercises with inspiratory load has the aim to trainning inspiratory muscle in strength and endurance, thus, could help to prevent postoperative complications.

Load inspiratory breathing exercises

Conventional Respiratory Physiotherapy (CRP) PROCEDURE

CRP consisted of diaphragmatic respiratory exercises, deep inhalation exercises, inhalations fragmented two to three times and respiratory exercises associated with shoulder flexion movements and extension of the upper limbs. One series of 10 repetitions was carried out for each exercise. Walking sessions and preventive exercises for deep vein thrombosis were carried out

Bilevel positive airway pressure; Control; Load inspiratory breathing exercises

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Metodista de Piracicaba: lead

Study Sites (1)

Universidade Metodista de Piracicaba

Piracicaba, São Paulo, 13400911, Brazil

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Eli Maria Pazzianotto-Forti, PhD

  Universidade Metodista de Piracicaba

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: February 15, 2016
• Study Start: November 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 17, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)