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

U

Universidade Metodista de Piracicaba

Status

Completed

Conditions

Inadequate or Impaired Respiratory Function

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02682771
UMetodistaPiracicaba

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

Female

Ages

25 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Triple Blind

60 participants in 3 patient groups

Control
Active Comparator group
Description:
Individuals were treated with Conventional Respiratory Physiotherapy (CRP), twice in immediate postoperative day and three times in first postoperative day.
Treatment:
Procedure: Conventional Respiratory Physiotherapy (CRP)
Bilevel positive airway pressure
Experimental group
Description:
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
Treatment:
Device: Bilevel positive airway pressure
Procedure: Conventional Respiratory Physiotherapy (CRP)
Load inspiratory breathing exercises
Experimental group
Description:
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.
Treatment:
Procedure: Conventional Respiratory Physiotherapy (CRP)
Device: PowerBreathe

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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