Respiratory Physiotherapy as a Tool to Increase the Number of Solid Organ Donors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- The changes in Oxygenation
研究概览
简要总结
The main objective of the project is to determine the variation of PaO2 / FiO2 (PaFi) after the use of mechanical insufflation-exsufflation (MI-E) or mechanical cough assistant in the donor in brain death (DBD) and in the potential donor in control donor after circulatory death (cDCD) It is a randomized prospective multicentre study. Four centres with a solid organ donation program will participate in the study, the Hospital Clínic i Provincial de Barcelona (HCB), the Germans Tries y Pujol Hospital (HGTP), the Marqués de Valdecilla Hospital (HMV) and the Vall d'Hebron Hospital (HVH). One hundred and sixty consecutive eligible donors will be included in DBD and cDCD older than 18 years.
- P1: Eighty donors will be maintained following national guidelines.
- P2: Eighty donors will be maintained following national guidelines and:
- Manual techniques of secretion drainage
- Two sequences separated for 1 min of 6 cycles each of MI-E(Cough Assist E70, Respironics Philips.
Demographic variables of the donor and recipient will be collected, as well as differences in PaFi, static compliance, and radiographic changes between P1 and P2 donors. The percentage of lung donors recovered by P2 with respect to P1 will be analyzed.
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
- 否
入选标准
- •Organ donor older than 18yo
排除标准
- •Absolute contraindications for MIE's use
- •Absolute contraindications for organ donation
结局指标
主要结局
The changes in Oxygenation
时间窗: Ten minutes after the MIE application and 60 minutes after MIE application or national protocol aplication
The changes of oxygenation comparing MIE to national protocol
次要结局
- Rate of complications with the use of MIE(During the intervention and 60 minutes after it.)
- Number of lung donors(during the recruitment time)
- Number of potential lung donors(during the recruitment time)
研究者
Irene Bello
Professor
Institut d'Investigacions Biomèdiques August Pi i Sunyer
