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临床试验/NCT01789177
NCT01789177已完成不适用

Use of Disposable Spirometer for Recovery of Pulmonary Function by Peak Expiratory Flow Measurement Following Exploratory Laparotomy

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2013年1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
150
试验地点
1
主要终点
Return to baseline or predicted pulmonary function

研究概览

简要总结

We hypothesize that the addition of modified incentive spirometry to standard postoperative chest physiotherapy will be associated with faster return to baseline/predicted pulmonary function and fewer postoperative pulmonary complications in patients following laparotomy.

详细描述

The primary objective of this study is to determine how quickly patients' peak expiratory flow measurement returns to baseline or predicted values following laparotomy with or without the assistance of modified incentive spirometry. The secondary objective is to assess the effectiveness of modified incentive spirometry in preventing postoperative pulmonary complications in patients following laparotomy. Specifically, this study will track length of stay, mortality, and evidence of pulmonary infection in both treatment and non-treatment arms.

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
None

入排标准

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

入选标准

  • •Adult patients who undergo laparotomy at Kamuzu Central Hospital, Malawi

排除标准

  • •Patients with known pre-existing pulmonary disease
  • •Pregnant women
  • •Patients who cannot perform maximal expiration for measurement of peak expiratory flow meter because of inability to understand or follow directions and demonstrations
  • •Patients with terminal cancer or illness with life-expectancy less than 1 month
  • •Patients with burn injuries
  • •Patients with illness requiring intubation and mechanical ventilation or postoperative ICU admission
  • •Patients who require additional operations during the course of their hospital stay

研究组 & 干预措施

Modified incentive spirometry

Experimental

Patients will be given a disposable incentive spirometer postoperatively and instructed to use the spirometer every hour while awake.

干预措施: Incentive Spirometry (Device)

Modified incentive spirometry

Experimental

Patients will be given a disposable incentive spirometer postoperatively and instructed to use the spirometer every hour while awake.

干预措施: Postoperative chest physiotherapy (Other)

Postoperative chest physiotherapy

Active Comparator

Patients will be given standard postoperative chest physiotherapy, according to hospital protocol, but will not receive incentive spirometers.

干预措施: Postoperative chest physiotherapy (Other)

结局指标

主要结局

Return to baseline or predicted pulmonary function

时间窗: postoperative course up to discharge

Return to baseline/predicted pulmonary function based on peak expiratory flow measurement. Postoperative measurement will be compared to preoperative measurement (for elective cases) or age-predicted measurement (for emergency cases)

次要结局

  • Incidence of postoperative pulmonary complications(postoperative course until discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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