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Completed

NCT Number: NCT01872663

Influence of Different Physical Therapy Resources Application After Reduction Stomach Surgery

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.

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Key information

Conditions

Pulmonary Atelectasis Body Weight Lung Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Metodista de Piracicaba (UNIMEP)

Piracicaba, São Paulo, 13400911, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Positive Airway Pressure

Procedure

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.

Incentive spirometry

Procedure

The volume of incentive spirometry (Voldyne ®) is able to provide increased transpulmonary pressure gradient, which can prevent or reverse atelectasis.

Breath Stacking

Procedure

The method allowed to obtain a maximum lung expansion with minimal patient compliance.

Expiratory Positive Airway Pressure

Procedure

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.

Intermittent positive pressure breathing

Procedure

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.

Bi-level positive airway pressure

Procedure

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.

Primary outcomes

  1. Pulmonary function

    Time frame: 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 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 outcomes

  1. Prevalence of atelectasis

    Time frame: 2 days after surgery

    The radiological report on the inspiration radiography, issued by the hospital radiologist, was used to analyze the presence of atelectasis.

  2. Thoracoabdominal mobility

    Time frame: 2 days after surgery

    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.

  3. Peak cough flow

    Time frame: 2 days after surgery

    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.

Sponsors and collaborators

Lead sponsor

Universidade Metodista de Piracicaba

Other

Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Registry information

Official study title

Influence of Different Physical Therapy Resources Application After Abdominal Surgery

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 7, 2013
Registry last updated
Dec 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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