Influence of Different Physical Therapy Resources Application After Reduction Stomach Surgery

This study has been completed.
Sponsor:
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Eli Maria Pazzianotto Forti, Universidade Metodista de Piracicaba
ClinicalTrials.gov Identifier:
NCT01872663
First received: June 4, 2013
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

The aim of this study will be to investigate the effects of using physical therapy resources in the postoperative morbidly obese individuals undergoing gastroplasty.

It is believed that the application of these various features of physiotherapy after abdominal surgery may contribute differently in restoring lung function and prevention of pulmonary complications and can thus identify the resources that can contribute more effectively in post-operative bariatric surgery.


Condition Intervention
Pulmonary Atelectasis
Respiratory Tract Diseases
Pathological Conditions, Signs and Symptoms
Procedure: Continuous positive airway pressure
Procedure: Incentive spirometry
Procedure: Breath Stacking
Procedure: Expiratory Positive Airway Pressure
Procedure: Intermittent positive pressure breathing
Procedure: Bi-level positive airway pressure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Different Physical Therapy Resources Application After Abdominal Surgery

Resource links provided by NLM:


Further study details as provided by Universidade Metodista de Piracicaba:

Primary Outcome Measures:
  • Pulmonary function [ Time Frame: 2 days after surgery ] [ Designated as safety issue: No ]
    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 lung volumes and flows: Slow Vital Capacity (SVC), Forced Vital Capacity (FVC) and Maximum Voluntary Ventilation (MVV). The maneuvers were carried out until three acceptable and reproducible curves were obtained, not exceeding more than eight attempts. 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:
  • Prevalence of atelectasis [ Time Frame: 2 days after surgery ] [ Designated as safety issue: No ]
    The radiological report on the inspiration radiography, issued by the hospital radiologist, was used to analyze the presence of atelectasis.

  • Thoracoabdominal mobility [ Time Frame: 2 days after surgery ] [ Designated as safety issue: No ]
    The measurement of thoracoabdominal mobility was performed by using a tape scaled in centimeters. In the standing position, the measurements 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 the lowest of expiration. The absolute difference between these values was considered the thoracoabdominal mobility.

  • Peak cough flow [ Time Frame: 2 days after surgery ] [ Designated as safety issue: No ]
    The peak flow measured during a cough maneuver will be measured by the equipment Peak Flow ®. For this, the volunteer will be instructed to place the mouthpiece between the lips of the equipment and play a cough with nostrils occluded nose clip. The maneuver should be repeated three times and the best preoperative measures will be compared to the best postoperative measurement.


Enrollment: 140
Study Start Date: August 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Incentive spirometry (Voldyne®)
Individuals will be treated with incentive spirometry, Voldyne Model 5000® in the immediate and the first postoperative day, twice a day, in sessions of 6 sets of 15 repetitions each, with an interval of four hours between them.
Procedure: Incentive spirometry
The volume of incentive spirometry (Voldyne ®) is able to provide increased transpulmonary pressure gradient, which can prevent or reverse atelectasis.
Experimental: Continuous positive airway pressure
Individuals will be treated with flow generator(Whisperflow, Caradyne, Ireland)and valve PEEP type spring-loaded which remain 10 cmH2O, in the immediate and the first postoperative day, twice a day, in sessions 30 minutes each, with an interval of four hours between them.
Procedure: Continuous positive airway pressure
The use of positive pressure airway seeking 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: Expiratory Positive Airway Pressure
The use of positive pressure airway seeking 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.
Experimental: Expiratory Positive Airway Pressure
Subjects will be treated with oronasal mask affixed to the face, with the PEEP valve set at 10 cmH2O, in the immediate and the first postoperative day, twice a day, in sessions of 6 sets of 15 repetitions each, with an interval of four hours between them.
Procedure: Continuous positive airway pressure
The use of positive pressure airway seeking 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: Expiratory Positive Airway Pressure
The use of positive pressure airway seeking 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.
Experimental: Intermittent positive pressure breathing
Subjects will be treated with application of Müller Resuscitator (Engesp®) through a nozzle, using a pressure endotracheal 20-30 cmH2O, refering to 2-3 kgf/cm², adjusted throttle valve oxygen, according to the patient's comfort and the micronebulizer coupled only saline as the diluent. The procedure will be performed in the immediate and the first postoperative day, twice a day, in sessions of 6 sets of 15 repetitions each, with an interval of four hours between them.
Procedure: Continuous positive airway pressure
The use of positive pressure airway seeking 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: Intermittent positive pressure breathing
The use of positive pressure airway seeking 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.
Experimental: Bi-level positive airway pressure
Individuals will be treated with positive pressure in the BiPAP mode (Bi-level positive airway pressure) in the immediate and the first postoperative day, twice a day, in sessions 30 minutes each, with an interval of four hours between them.
Procedure: Continuous positive airway pressure
The use of positive pressure airway seeking 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: Expiratory Positive Airway Pressure
The use of positive pressure airway seeking 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: Bi-level positive airway pressure
The use of positive pressure airway seeking 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.
Experimental: Breath Stacking
Subjects will be treated with a siliconized mask connected to a unidirectional valve and adapted to the patient's face, allowing only the inspiration and the expiratory limb remains occluded, while the volunteer is instructed to perform successives inspiratory efforts, in the immediate and the first postoperative day, twice a day, in sessions of 6 sets of 15 repetitions each, with an interval of four hours between them.
Procedure: Breath Stacking
The method allowed to obtain a maximum lung expansion with minimal patient compliance.
No Intervention: Control
Individuals will be treated with conventional physiotherapy according to the routine service of physiotherapy of the hospital.

Detailed Description:

The aim of this study will be to investigate the effects of using physical therapy resources in the postoperative morbidly obese individuals undergoing Roux-en-Y gastric by-pass with regard to: lung volumes and capacities, prevalence of atelectasis, thoracoabdominal mobility and evaluation of peak flow of cough, evaluated pre and post operative.

Individuals with BMI between 40 and 55 Kg/m², aged between 25 and 55 years, underwent the surgical procedure Roux-en-Y type gastric by-pass by laparotomy and normal preoperative pulmonary function will be included.

The volunteers will be divided into seven different groups, according to the treatment received during hospitalization after surgery:

G control: subjects treated with conventional physiotherapy according to the routine service of physiotherapy of the hospital; G Voldyne: subjects treated with incentive spirometry, Voldyne Model 5000® (Sherwood Medical, USA); G CPAP: subjects treated with "continuous positive airway pressure"; G EPAP: subjects treated with "expiratory positive airway pressure"; G IPPB: subjects treated with "intermittent positive pressure breathing"; G BIPAP: subjects treated with "bi-level positive airway pressure"; G BS: subjects treated with "breath stacking" (siliconized mask connected to a unidirectional valve allowing only inspiration).

The application of resources will be held twice a day in the immediate and in the first postoperative sessions in 6 sets of 15 reps or 30 continuous minutes, with an interval of 4 hours between sessions. The researcher will remain alongside the volunteers, following them and monitoring vital signs and respiratory comfort.

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI between 40 and 55 Kg/m²
  • Aged between 25 and 55 years
  • Submitted to Roux-en-Y type gastric by-pass by laparotomy
  • Normal preoperative pulmonary function test

Exclusion Criteria:

  • Hemodynamic instability
  • Hospital stay longer than three days
  • Presence of postoperative complications
  • Smoking
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01872663

Locations
Brazil
Universidade Metodista de Piracicaba (UNIMEP)
Piracicaba, São Paulo, Brazil, 13400911
Sponsors and Collaborators
Universidade Metodista de Piracicaba
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  More Information

No publications provided

Responsible Party: Eli Maria Pazzianotto Forti, PhD, Universidade Metodista de Piracicaba
ClinicalTrials.gov Identifier: NCT01872663     History of Changes
Other Study ID Numbers: Patricia2013, UNIMEP2013
Study First Received: June 4, 2013
Last Updated: December 2, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Metodista de Piracicaba:
Morbid obesity
Bariatric surgery
Pulmonary atelectasis
Spirometry
Continuos Positive Airway Pressure
Physical therapy speciality

Additional relevant MeSH terms:
Signs and Symptoms
Respiratory Tract Diseases
Pulmonary Atelectasis
Lung Diseases

ClinicalTrials.gov processed this record on September 18, 2014