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临床试验/NCT01828632
NCT01828632已完成不适用

Effects of Preoperative Respiratory Physical Therapy on Postoperative Respiratory Function in Morbidly Obese Patients Undergoing Bariatric Surgery. A Randomized, Controlled, Clinical Trial

Fundación para la Investigación del Hospital Clínico de Valencia2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2011年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
2
主要终点
Intergroup difference in Arterial Oxygen partial pressure / Inspired Oxygen Fraction ratio (PaO2/FiO2)

研究概览

简要总结

Background. Morbidly obese patients show an increased risk of hypoxemia and a higher incidence of postoperative pulmonary complications during the postoperative period resulting in prolonged hospital length of stay when compared with normal weight subjects. Preoperative respiratory physiotherapy including inspiratory muscle training (IMT) has been shown to reduce the incidence of post operative respiratory complications in some different settings.

Objective. To determine wether a program of preoperative respiratory physical therapy could reduce the incidence and severity of postoperative hypoxemia in morbidly obese patients undergoing laparoscopic bariatric surgery.

Setting. Hospital Clínico Universitario, Valencia, Spain.

Design and Patients. A double-blind, randomized clinical trial. 50 patients (BMI≥40%) consecutively scheduled for laparoscopic bariatric surgery were included of whom 44 completed the study. Sample size was calculated using the repeated measures of the PaO2/FiO2 ratio along the postoperative period as the primary endpoint and considering an effect size of 0.25.

Interventions. Patients were randomly assigned to receive either preoperative respiratory physical therapy (n=23) or usual care (n=21) during a month just before the date of surgery. Both groups received the same postoperative physical therapy.

Measures. Data on oxygenation (primary outcome, PaO2/Fio2 ratio) were obtained at 1hour and at 12 hours after surgery. Data on spirometry and maximum static respiratory pressures (secondary outcomes) were obtained before and after the training period, and in the postoperative period.

详细描述

Background. Morbidly obese patients show an increased risk of hypoxemia during the postoperative period resulting in a higher incidence of postoperative pulmonary complications and prolonged hospital length of stay when compared with normal weight subjects. Mechanisms involved in this predisposition of morbidly obese patients for develop this physiopathologic scheme include a greater impairment on the respiratory mechanics induced by general anesthesia and paralysis -greater reduction in pulmonary and chest compliances and higher airway resistance- and an increment in ventilatory requirements. That leads to an increased work of breathing (WOB) and oxygen consumption (VO2). These effects are exaggerated in patients undergoing laparoscopic surgery because the direct effects of the pneumoperitoneum on the pulmonary mechanics. In addition, in morbidly obese patients respiratory muscles show a reduction in both strength and endurance probably a cause of the fatty tissular infiltration and the exacerbated inflammatory response usually observed in these patients.

Respiratory physical therapy has shown to be effective and reduce postoperative pulmonary complications both, as postoperative treatment and when given preoperatively. When applied postoperatively respiratory physiotherapy has proved to be able to expand pulmonary volumes and to improve arterial oxygenation, leading to decreases in postoperative pulmonary complications, specially after abdominal surgery. In the specific setting of morbidly obese patients submitted to bariatric surgery, postoperative inspiratory muscle training (IMT ) improves inspiratory muscle strength and endurance allowing an earlier recovery of pulmonary airflows.

There are scanty data about the results of applying respiratory physiotherapy on the preoperative period. However it has proved to be able to reduce the postoperative incidence of postoperative pulmonary complications in some different settings: (1) In patients after thoracic surgery, (2) In patients undergoing CABG surgery, specially in those considered at high risk for pulmonary complications and (3) after upper abdominal surgery.

At our knowledge no studies aimed to determine wether preoperative respiratory physiotherapy could improve the postoperative respiratory function in morbidly obese patients have been published.

The objective of this study was to evaluate the effects of a preoperative respiratory physical therapy program on the postoperative respiratory function in morbidly obese patients undergoing bariatric laparoscopic surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult morbidly obese patients (BMI>40%) consecutively scheduled for bariatric surgery

排除标准

  • Age > 65 years
  • Pregnancy
  • Severe psychiatric disorders
  • Disability to perform a valid spirometry and/or correctly use IMT and incentive spirometer devices
  • Bronchial asthma requiring regular therapy
  • Smoking less than two months before surgery
  • Chronic obstructive pulmonary disease
  • Restrictive lung disease or lung surgery
  • Cardiac disease associated with dyspnoea > NYHA II

结局指标

主要结局

Intergroup difference in Arterial Oxygen partial pressure / Inspired Oxygen Fraction ratio (PaO2/FiO2)

时间窗: Two Time Points: At one and at twelve hours after the patients's arrival to the post-anesthesia care unit

次要结局

  • Intragroup and intergroup differences in Maximal Inspiratory Pressure (MIP)(Two Time Points: At the end of the physiotherapy program and at twelve hours after the arrival to the PACU,compared with the baseline values.)
  • Intergroup difference in Arterial carbon dioxide (PaCO2)(Two Time Points: At one and at twelve hours after the patients's arrival to the post-anesthesia care unit)

研究者

发起方
Fundación para la Investigación del Hospital Clínico de Valencia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Julio Llorens

MD, PhD

Fundación para la Investigación del Hospital Clínico de Valencia

研究点 (2)

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