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临床试验/NCT01872663
NCT01872663已完成不适用

Influence of Different Physical Therapy Resources Application After Abdominal Surgery

Universidade Metodista de Piracicaba1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2013年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
1
主要终点
Pulmonary function

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
25 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

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

研究组 & 干预措施

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.

干预措施: Incentive spirometry (Procedure)

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.

干预措施: Continuous positive airway pressure (Procedure)

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.

干预措施: Expiratory Positive Airway Pressure (Procedure)

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.

干预措施: Continuous positive airway pressure (Procedure)

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.

干预措施: Expiratory Positive Airway Pressure (Procedure)

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.

干预措施: Continuous positive airway pressure (Procedure)

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.

干预措施: Intermittent positive pressure breathing (Procedure)

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.

干预措施: Continuous positive airway pressure (Procedure)

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.

干预措施: Expiratory Positive Airway Pressure (Procedure)

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.

干预措施: Bi-level positive airway pressure (Procedure)

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.

干预措施: Breath Stacking (Procedure)

Control

No Intervention

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

结局指标

主要结局

Pulmonary function

时间窗: 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.

次要结局

  • Prevalence of atelectasis(2 days after surgery)
  • Thoracoabdominal mobility(2 days after surgery)
  • Peak cough flow(2 days after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eli Maria Pazzianotto Forti

PhD

Universidade Metodista de Piracicaba

研究点 (1)

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