Influence of Different Physical Therapy Resources Application After Reduction Stomach Surgery

NCT01872663 | Completed

• 2 other identifiers: Patricia2013UNIMEP2013
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Atelectasis; Respiratory Tract Diseases; Pathological Conditions, Signs and Symptoms

Keywords

Morbid obesity; Bariatric surgery; Pulmonary atelectasis; Spirometry; Continuos Positive Airway Pressure; Physical therapy speciality

Outcome Measures

Primary Outcomes (1)

• Pulmonary function

  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.

  2 days after surgery

Secondary Outcomes (3)

• Prevalence of atelectasis

  2 days after surgery

• Thoracoabdominal mobility

  2 days after surgery

• Peak cough flow

  2 days after surgery

Study Arms (7)

Incentive spirometry (Voldyne®)

EXPERIMENTAL

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

Continuous positive airway pressure

EXPERIMENTAL

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; Procedure: Expiratory Positive Airway Pressure

Expiratory Positive Airway Pressure

EXPERIMENTAL

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; Procedure: Expiratory Positive Airway Pressure

Intermittent positive pressure breathing

EXPERIMENTAL

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; Procedure: Intermittent positive pressure breathing

Bi-level positive airway pressure

EXPERIMENTAL

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; Procedure: Expiratory Positive Airway Pressure; Procedure: Bi-level positive airway pressure

Breath Stacking

EXPERIMENTAL

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

Control

NO INTERVENTION

Individuals will be treated with conventional physiotherapy according to the routine service of physiotherapy of the hospital.

Interventions

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.

Bi-level positive airway pressure; Continuous positive airway pressure; Expiratory Positive Airway Pressure; Intermittent positive pressure breathing

Incentive spirometry PROCEDURE

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

Incentive spirometry (Voldyne®)

Breath Stacking PROCEDURE

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

Breath Stacking

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.

Bi-level positive airway pressure; Continuous positive airway pressure; Expiratory Positive Airway Pressure

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.

Intermittent positive pressure breathing

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.

Bi-level positive airway pressure

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Hemodynamic instability
• Hospital stay longer than three days
• Presence of postoperative complications
• Smoking

Sponsors & Collaborators

• Universidade Metodista de Piracicaba: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

Universidade Metodista de Piracicaba (UNIMEP)

Piracicaba, São Paulo, 13400911, Brazil

Location

Related Publications (1)

• Brigatto P, Carbinatto JC, Costa CM, Montebelo MI, Rasera-Junior I, Pazzianotto-Forti EM. Application of positive airway pressure in restoring pulmonary function and thoracic mobility in the postoperative period of bariatric surgery: a randomized clinical trial. Braz J Phys Ther. 2014 Nov-Dec;18(6):553-62. doi: 10.1590/bjpt-rbf.2014.0054. Epub 2015 Jan 9.

  PMID: 25590448 DERIVED

MeSH Terms

Conditions

Pulmonary Atelectasis; Respiratory Tract Diseases; Pathological Conditions, Signs and Symptoms; Obesity, Morbid

Interventions

Continuous Positive Airway Pressure; Intermittent Positive-Pressure Breathing

Condition Hierarchy (Ancestors)

Lung Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 7, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 3, 2013

Record last verified: 2013-12

Locations

BR (1)