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Influence of Different Physical Therapy Resources Application After Reduction Stomach Surgery

U

Universidade Metodista de Piracicaba

Status

Completed

Conditions

Pulmonary Atelectasis
Respiratory Tract Diseases
Pathological Conditions, Signs and Symptoms

Treatments

Procedure: Bi-level positive airway pressure
Procedure: Continuous positive airway pressure
Procedure: Incentive spirometry
Procedure: Expiratory Positive Airway Pressure
Procedure: Intermittent positive pressure breathing
Procedure: Breath Stacking

Study type

Interventional

Funder types

Other

Identifiers

NCT01872663
Patricia2013
UNIMEP2013 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 patients

Sex

All

Ages

25 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

140 participants in 7 patient groups

Incentive spirometry (Voldyne®)
Experimental group
Description:
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.
Treatment:
Procedure: Incentive spirometry
Continuous positive airway pressure
Experimental group
Description:
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.
Treatment:
Procedure: Continuous positive airway pressure
Procedure: Expiratory Positive Airway Pressure
Expiratory Positive Airway Pressure
Experimental group
Description:
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.
Treatment:
Procedure: Continuous positive airway pressure
Procedure: Expiratory Positive Airway Pressure
Intermittent positive pressure breathing
Experimental group
Description:
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.
Treatment:
Procedure: Continuous positive airway pressure
Procedure: Intermittent positive pressure breathing
Bi-level positive airway pressure
Experimental group
Description:
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.
Treatment:
Procedure: Bi-level positive airway pressure
Procedure: Continuous positive airway pressure
Procedure: Expiratory Positive Airway Pressure
Breath Stacking
Experimental group
Description:
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.
Treatment:
Procedure: Breath Stacking
Control
No Intervention group
Description:
Individuals will be treated with conventional physiotherapy according to the routine service of physiotherapy of the hospital.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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