Influence of Different Physical Therapy Resources Application After Reduction Stomach Surgery

Respiratory Tract Diseases Clinical Trial

Official title:

Influence of Different Physical Therapy Resources Application After Abdominal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01872663
• Other study ID #: Patricia2013
• Secondary ID: UNIMEP2013
• Status: Completed
• Phase: N/A
• First received: June 4, 2013
• Last updated: December 2, 2013
• Start date: August 2013
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Universidade Metodista de Piracicaba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.
• Incentive spirometry
The volume of incentive spirometry (Voldyne ®) is able to provide increased transpulmonary pressure gradient, which can prevent or reverse atelectasis.
• Breath Stacking
The method allowed to obtain a maximum lung expansion with minimal patient compliance.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Universidade Metodista de Piracicaba (UNIMEP)	Piracicaba	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Metodista de Piracicaba	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Prevalence of atelectasis	The radiological report on the inspiration radiography, issued by the hospital radiologist, was used to analyze the presence of atelectasis.	2 days after surgery	No
Secondary	Thoracoabdominal mobility	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.	2 days after surgery	No
Secondary	Peak cough flow	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.	2 days after surgery	No