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临床试验/NCT02682771
NCT02682771已完成不适用

Effects of Positive Airway Pressure and Incentive With Load Inspiratory on Lung Function and Respiratory Muscle in Post-bariatric Surgery - a Randomized and Blind Clinical Trial

Universidade Metodista de Piracicaba1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年11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
60
试验地点
1
主要终点
Pulmonary function

研究概览

简要总结

Obesity, due to excess fat in the thoracoabdominal region, can promote changes in respiratory function and lung function, leading to reduction in lung volume and capacity. Such dysfunctions are worsen after bariatric surgery to be associated with factors inherent to this procedure. The objective of this study was to evaluate and compare the effects of the application of bilevel positive airway pressure and exercises with inspiratory pressure with linear load in thoracoabdominal mobility, pulmonary function, inspiratory muscle strength, respiratory muscle strength and prevalence of pulmonary complications after bariatric surgery.

详细描述

This is a clinical trial, randomized, blinded, in which 60 volunteers, after evaluation preoperatively, consisting of: cirtometry to measure thoracoabdominal mobility, spirometry for measures of lung function, nasal inspiratory pressure to inspiratory muscle strength and endurance incremental test for evaluation of respiratory muscle strength, were randomized and allocated into three groups, with 20 volunteers each. The interventions were performed in the immediate postoperative period and the first day after surgery. The first group, called the control group received care by Conventional Respiratory Physiotherapy (CRP), consisting of breathing exercises, incentive spirometer and ambulation. The second group, called Positive Pressure Group received two-level positive airway pressure for one hour, addition of CRP. The third group, called Load Inspiratory Group held exercises with inspiratory pressure with linear load, linked also to the CRP. Treatments were applied twice in the immediate postoperative period and shortly after returning to the ward and after 4 hours of the initial treatment and three times a day on the first day after surgery. On discharge, the second day after surgery, the volunteers performed chest x-ray and underwent the same evaluations performed preoperatively.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •Submitted to Roux-en-Y type gastric bypass by laparotomy
  • •Normal preoperative pulmonary function and chest x-ray

排除标准

  • •Hemodynamic instability
  • •Hospital Stay longer than three days
  • •Presence of postoperative complications
  • •Respiratory chronic diseases

研究组 & 干预措施

Control

Active Comparator

Individuals were treated with Conventional Respiratory Physiotherapy (CRP), twice in immediate postoperative day and three times in first postoperative day.

干预措施: Conventional Respiratory Physiotherapy (CRP) (Procedure)

Bilevel positive airway pressure

Experimental

Individuals were treated with positive pressure, in the BIPAP mode (bilevel positive airway pressure, with inspiratory pressure:12 cmH20 and expiratory pressure: 8 cmH20) twice in the immediate postoperative day and three times in first postoperative day, in sessions 1 hour each

干预措施: Bilevel positive airway pressure (Device)

Bilevel positive airway pressure

Experimental

Individuals were treated with positive pressure, in the BIPAP mode (bilevel positive airway pressure, with inspiratory pressure:12 cmH20 and expiratory pressure: 8 cmH20) twice in the immediate postoperative day and three times in first postoperative day, in sessions 1 hour each

干预措施: Conventional Respiratory Physiotherapy (CRP) (Procedure)

Load inspiratory breathing exercises

Experimental

Individuals were treat with PowerBreathe, a device for inspiratory muscle, with 40% maximal inspiratory pressure, measured at preoperative, twice in the immediate postoperative day and three times in first postoperative day, in sessions 1 hour each.

干预措施: PowerBreathe (Device)

Load inspiratory breathing exercises

Experimental

Individuals were treat with PowerBreathe, a device for inspiratory muscle, with 40% maximal inspiratory pressure, measured at preoperative, twice in the immediate postoperative day and three times in first postoperative day, in sessions 1 hour each.

干预措施: Conventional Respiratory Physiotherapy (CRP) (Procedure)

结局指标

主要结局

Pulmonary function

时间窗: up to 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 lumg volumes and flows: slow vital capacity, forced vital capacity and maximum voluntary ventilation. The maneuvers were carried out until three acceptable and reproducible curves were obtained, not exceeding more than eight attemps. 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

  • Thoracoabdominal mobility(up to 2 days after surgery)
  • Evaluation of inspiratory muscle endurance(up to 2 days after surgery)
  • Evaluation of muscle strength inspiratory(up to 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

Principal Investigator

Universidade Metodista de Piracicaba

研究点 (1)

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