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临床试验/NCT00418158
NCT00418158已完成不适用

Pulmonary Complications After Heart Surgery

Catharina Ziekenhuis Eindhoven2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2005年12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
120
试验地点
2

研究概览

简要总结

Abstract: Post-operative pulmonary complications after cardiac surgery

Background The Catharina Hospital performs approximately 1700 heart operation each year. One third of the patients stay at the Catharina hospital during their entire post-operative period. Two years ago they abolished the pulmonary support by a physiotherapist. Subjectively, the pulmonary complications increased over the last two years. During an investigation of the contentment of the patients an increase of the pulmonary problems came forward after eliminating the pulmonary support. There have been no further examinations to the pulmonary complications post-operatively.

Objectives The aim of this study is to give the department of cardio-thoracic surgery an advice about the post-operative pulmonary support for patients who underwent heart surgery.

During the study a budgetary analysis will be made.

Methods 120 patients are prospectively randomised in three groups. Randomisation takes place through block randomisation every three weeks. 40 patients will be supported by a physiotherapist. Another 40 patients will be supported by the nurses on the cardiothoracic surgery ward and the last 40 patients will use an incentive therapy with 'Airlife' by a self-management method.

The study population are all patients undergoing heart surgery and spend their entire post-operative period at the Catharina Hospital. In- and exclusion criteria are specified in the protocol on pages 3 and 4.

Outcome The primary outcome is to qualify the pulmonary complications within the three groups. These complications will be objectified by measuring peak flow, an instrument to determine the lung function, and an x-ray of the thorax.

The secondary outcome is the contentment of the patient, which will be determined by a VAS-score (Visual Analogue Scale).

Risks There are no risks for the patient when participating on this study. The patient will have to fill in the VAS-score and measure lung function with the peak flow at two different moments. The study takes place in a clinical setting. There is no extra insurance in conformity with the advice of the METC.

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
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

入选标准

  • Euroscore < 8
  • Age > 18 year
  • Patients whereby ECC is peri-operatively used
  • No psychological history
  • Informed consent obtained
  • Follow -up at Catherina Hospital

排除标准

  • Mitral valve plasty or reconstruction
  • Cognitive problems
  • Expected comlpications during operation
  • Patients with decompensation
  • Day 5 post- ok thoracic drains insitu
  • Pain score grater than 4
  • Abnormal chest x-ray

研究者

发起方
Catharina Ziekenhuis Eindhoven
申办方类型
Other

研究点 (2)

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