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

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ClinicalTrials.gov Identifier: NCT02682771
Recruitment Status : Completed
First Posted : February 15, 2016
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Eli Maria Pazzianotto Forti, 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.

Condition or disease Intervention/treatment Phase
Inadequate or Impaired Respiratory Function Device: Bilevel positive airway pressure Device: PowerBreathe Procedure: Conventional Respiratory Physiotherapy (CRP) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control
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)
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

Experimental: Bilevel positive airway pressure
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
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

Procedure: Conventional Respiratory Physiotherapy (CRP)
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

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

Procedure: Conventional Respiratory Physiotherapy (CRP)
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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Thoracoabdominal mobility [ Time Frame: up 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.

  2. Evaluation of inspiratory muscle endurance [ Time Frame: up 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.

  3. Evaluation of muscle strength inspiratory [ Time Frame: up 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



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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682771


Locations
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Brazil
Universidade Metodista de Piracicaba
Piracicaba, São Paulo, Brazil, 13400911
Sponsors and Collaborators
Universidade Metodista de Piracicaba
Investigators
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Principal Investigator: Eli Maria Pazzianotto-Forti, PhD Universidade Metodista de Piracicaba
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Responsible Party: Eli Maria Pazzianotto Forti, Principal Investigator, Universidade Metodista de Piracicaba
ClinicalTrials.gov Identifier: NCT02682771    
Other Study ID Numbers: UMetodistaPiracicaba
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Eli Maria Pazzianotto Forti, Universidade Metodista de Piracicaba:
gastroplasty, breathing exercices, positive pressure
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases