A Prospective Randomised Two Month Trial Comparing Twho Chest Physiotherapy Protocols in Lung Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Lung function
研究概览
简要总结
Chest infection is a common complication following lung transplant (LTx). Chest physiotherapy is widely accepted as an integral part of the management of chest infections, however there is no evidence available regarding the effectiveness of chest physiotherapy regimes for LTx recipients.
There is no consensus regarding whether LTx recipients should be instructed to perform regular daily chest physiotherapy routines regardless of the presence of lung secretions (ie prophylatically) because of the changes in mucus clearance bought about by lung transplant, or only when they have a chest infection. Some clinicians believe that a prophylactic regimen may be beneficial.
This research will compare two chest physiotherapy treatment regimens - our current practice of chest physiotherapy during chest infections only (Treatment A) with an independently performed daily chest physiotherapy regimen regardless of the presence of a chest infection (Treatment B). From this research, we aim to develop evidence-based treatment guidelines.
详细描述
Very little is known about the effectiveness of chest physiotherapy protocols in lung transplant recipients. Clinical practice is based upon the experiences of individual clinicians and generalisations from other patient populations.
There is anecdotal evidence (from discussion with physiotherapists at the European Cystic Fibrosis Conference, 2001) that some lung transplant centres are advising their patients to undertake daily (prophylactic) chest physiotherapy as part of their usual routine. They believe that this may compensate for the reduced stimulus to cough caused by the lack of vagal nerve supply to the transplanted lung/s.There is no evidence that this time consuming intervention is of any benefit to the patient in the short or longer term.
Some patients have bronchial anastomotic complications and dynamic airway collapse that may further impair secretion removal. The mechanical effects of Positive Expiratory Pressure (PEP) mask Physiotherapy, particularly its ability to splint open airways, provides a theoretical basis for why this technique may be beneficial to lung transplant recipients. We have also noted a clinical benefit in a small number of patients who have been treated with PEP.
This study aims to evaluate two chest physiotherapy protocols using a variety of outcome measures and act as a starting point for future/ongoing research in this important clinical area.
This study is a prospective randomised two month trail comparing two chest physiotherapy protocols in lung transplant recipients.
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
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All lung transplant recipients treated at The Alfred will be invited to participate in the study at three weeks following lung transplantation.
排除标准
- •ventilator dependent
- •tracheostomy insitu
- •pneumothorax
- •major myopathy
- •oxygen requirement of greater than 4 litres per minute
- •or any condition that prevents them from performing PEP mask chest physiotherapy at the time of recruitment to the study.
结局指标
主要结局
Lung function
Chest radiographic score -Brasfield Score
Bronchoscopy score
Days in hospital due to chest infection
Antibiotic use
Quality of Life - SF-36 Health Survey
Functional exercise capacity - 6 minute walk test
次要结局
- Patient adherence to the alternative protocols
- Patient satisfaction with the alternative protocols.