Clinical trial NCT02682771: Positive Airway Pressure Versus Breathing Exercises With Load Inspiratory in Patients Undergoing Bariatric Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inadequate or Impaired Respiratory Function
Keywords: gastroplasty, breathing exercices, positive pressure
Lead sponsor: Universidade Metodista de Piracicaba
Sponsor class: OTHER
First posted: 2016-02-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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
* Smoking
* Respiratory chronic diseases

Primary outcomes:
measure: Pulmonary function
timeFrame: up to 2 days after surgery
Secondary outcomes:
measure: Thoracoabdominal mobility
timeFrame: up to 2 days after surgery
measure: Evaluation of inspiratory muscle endurance
timeFrame: up to 2 days after surgery
measure: Evaluation of muscle strength inspiratory
timeFrame: up to 2 days after surgery
Other outcomes:
Locations:
city: Piracicaba
country: Brazil
facility: Universidade Metodista de Piracicaba
state: São Paulo
Study officials:
affiliation: Universidade Metodista de Piracicaba
name: Eli Maria Pazzianotto-Forti, PhD
role: PRINCIPAL_INVESTIGATOR
References: