跳至主要内容
临床试验/NCT04006587
NCT04006587已完成不适用

Incentive Spirometer Device Reduces Pulmonary Complications in Patients With Traumatic Rib Fractures

Chang Gung Memorial Hospital0 个研究点目标入组 50 人开始时间: 2014年6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
50
主要终点
pulmonary complication rate

研究概览

简要总结

The incentive spirometer (IS) is a mechanical device that helps lung expansion. It is commonly used to prevent postoperative lung atelectasis and decreased pulmonary complications in patients who received cardiac, lung, or abdomen surgery.This study aimed to explore the effect of the IS on the improvement of lung function and decrease in pulmonary complication rate in rib fractures patients.

详细描述

Adult patients (>18 years old) seen at our institution between June, 2014 until May, 2017 with traumatic rib fractures were included. For inclusion, a patient had to have at least one rib fracture as detected by chest X-ray (CXR) or computed tomography scan. We excluded patients with unconsciousness, history of chronic obstructive pulmonary disease, asthma, or an Injury Severity Score (ISS) ≥ 16. Patients were divided into two groups using a randomized envelope technique: in the study group, patients were advised to use the IS and in the control group patients did not received the IS. All patients were managed with the same oral analgesic protocol. A CXR was obtained on the 1st and 5th day of admission and performed by a radiologist. The Pulmonary Function Test (PFT) was administered on the 2nd and 7th day of admission and performed by a pulmonologist. A numeric rating scale (NRS) was used to define the severity of chest pain on the 1st and 5th day of admission.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

  • at least one rib fracture as detected by chest X-ray (CXR) or computed tomography scan

排除标准

  • unconsciousness,
  • history of chronic obstructive pulmonary disease
  • Injury Severity Score (ISS) ≥ 16

结局指标

主要结局

pulmonary complication rate

时间窗: 2 weeks after trauma

atelectasis, pneumonia, hemothorax, and pneumothorax

次要结局

  • 1st lung function test(2nd day of admission)
  • 1st Pain score(1st day of admission)
  • 2nd Pain score(5th day of admission)
  • 2nd lung function test(7th day of admission)
  • length of hospital stay(total hospital stay days up to 2 months after admission)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

相似试验