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

Not Applicable
Completed
Conditions
Inadequate or Impaired Respiratory Function
Interventions
Device: Bilevel positive airway pressure
Device: PowerBreathe
Procedure: Conventional Respiratory Physiotherapy (CRP)
Registration Number
NCT02682771
Lead Sponsor
Universidade Metodista de Piracicaba
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
60
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
  • Smoking
  • Respiratory chronic diseases

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
Bilevel positive airway pressureConventional Respiratory Physiotherapy (CRP)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
Bilevel positive airway pressureBilevel positive airway pressureIndividuals 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
Load inspiratory breathing exercisesConventional Respiratory Physiotherapy (CRP)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.
ControlConventional Respiratory Physiotherapy (CRP)Individuals were treated with Conventional Respiratory Physiotherapy (CRP), twice in immediate postoperative day and three times in first postoperative day.
Load inspiratory breathing exercisesPowerBreatheIndividuals 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.
Primary Outcome Measures
NameTimeMethod
Pulmonary functionup 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 Outcome Measures
NameTimeMethod
Thoracoabdominal mobilityup to 2 days after surgery

The measurement of thoracoabdominal mobility was performed by using a tape scaled in centimeters. In the standing position, the measurement 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 lowest of expiration. The absolute difference between these values was considered the thoracoabdominal mobility.

Evaluation of inspiratory muscle enduranceup to 2 days after surgery

The endurance test was performed using the PowerBreathe K3. An incremental test was performed, initiating at 30% of maximal inspiratory pressure for 30 respiratory cycles and then, added 10 cmH20 for each respiratory cycle. The test was finished when the individual was unabled to promote inspiratory effort.

Evaluation of muscle strength inspiratoryup to 2 days after surgery

The Sniff is an alternative non-invasive technique for the assessment of inspiratory muscle strength by sniff nasal inspiratory pressure (PNSN). The measurement is performed using a peak pressure generated by nasal nostril during a maximal sniff from functional residual capacity

Trial Locations

Locations (1)

Universidade Metodista de Piracicaba

🇧🇷

Piracicaba, São Paulo, Brazil

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