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临床试验/NCT01993602
NCT01993602已完成不适用

COMPARISON OF LUNG EXPANSION TECHNICS ON THORACOABDOMINAL MECHANICS AND THEIR INFLUENCE ON THE INCIDENCE OF PULMONARY COMPLICATIONS AFTER ABDOMINAL SURGERY: A RANDOMIZED AND CONTROLLED CLINICAL TRIAL

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 171 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
171
试验地点
2
主要终点
thoracoabdominal volume

研究概览

简要总结

The lung expansion techniques are widely used to prevent postoperative pulmonary complications. However, the effect of each technique on thoracoabdominal mechanics after abdominal surgery and if it influences the rate of postoperative pulmonary complications remains unknown. The investigators hypothesis is that the lung expansion technique that more increases lung volume after abdominal surgery, will be the most efficient in preventing postoperative pulmonary complication after abdominal surgery. The investigators objectives will be to compare the effect of different lung expansion techniques on lung volumes and activation of inspiratory muscle, and prevention of pulmonary complications in patients undergoing upper abdominal surgery. This study will involve 171 patients undergoing elective abdominal surgery. Patients will be randomly divided into 5 groups: no therapy group (n=35), continuous positive airway pressure (CPAP, n=34); volumetric incentive spirometry (VIS, n=34); flow oriented incentive spirometry (FIS, n=33) and deep breathing (DB, n=35). The thoracoabdominal mechanics will be assessed before and 3 days after surgery. Complications will be evaluated by a researcher who did not know to which group each patient belongs.

详细描述

The assessments performed were thoracoabdominal kinematics (by optoelectronic pletysmography)and respiratory muscles activity (by surface electromyography). The follow pulmonary complications were considered: pneumonia, tracheobronchitis, atelectasis and acute respiratory failed

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • candidates for elective upper abdominal surgery expected to last longer than 120 minutes
  • absent of spine or thoracic deformity
  • no previous lung parenchyma resection
  • no tracheostomy
  • able to understand and perform the maneuvers proposed.

排除标准

  • cancellation of surgery
  • mechanical ventilation for more than 24 hours in the postoperative period
  • need for chest tube use
  • postoperative cardiac complications
  • surgical complication
  • reoperation

结局指标

主要结局

thoracoabdominal volume

时间窗: third postoperative day

thoracoabdominal volume was evaluated by kinematics (optoelectronic plethysmograph)

次要结局

  • postoperative pulmonary complication(participants will be followed for the duration of hospital stay, an expected average of 10 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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