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

Vall d'Hebron Institute Research

Status: Enrolling

Conditions: Lung Transplant Failure

Treatments: Device: MIE

Study type: Interventional

Funder types: Other

Identifiers

NCT06202859

MIE-don study

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Organ donor older than 18yo

Exclusion criteria

• Absolute contraindications for MIE's use
• Absolute contraindications for organ donation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

MIE group

Experimental group

Description:

* Manual techniques of secretion drainage * Two sequences separated for 1 min of 6 cycles each of MI-E(Cough Assist E70, Respironics Philips.

Treatment:

Device: MIE

Control group

Active Comparator group

Description:

Maintained following national guidelines.

Treatment:

Device: MIE