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临床试验/NCT06202859
NCT06202859招募中不适用

Respiratory Physiotherapy as a Tool to Increase the Number of Solid Organ Donors

Vall d'Hebron Institute Research2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2022年11月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Irene Bello

Professor

Institut d'Investigacions Biomèdiques August Pi i Sunyer

研究点 (2)

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