Clinical trial NCT06202859: Respiratory Physiotherapy as a Tool to Increase the Number of Solid Organ Donors
Official title: Respiratory Physiotherapy as a Tool to Increase the Number of Solid Organ Donors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Transplant Failure
Keywords: respiratory physiotherapy
lung donor
improve lung donor
Lead sponsor: Vall d'Hebron Institute Research
Sponsor class: OTHER
Collaborators: name: Hospital Vall d'Hebron
name: Germans Trias i Pujol Hospital
name: Hospital Universitario Marqués de Valdecilla
First posted: 2024-01-12
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Organ donor older than 18yo

Exclusion Criteria:

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

Primary outcomes:
measure: The changes in Oxygenation
timeFrame: Ten minutes after the MIE application and 60 minutes after MIE application or national protocol aplication
Secondary outcomes:
measure: Rate of complications with the use of MIE
timeFrame: During the intervention and 60 minutes after it.
measure: Number of potential lung donors
timeFrame: during the recruitment time
measure: Number of lung donors
timeFrame: during the recruitment time
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Irene bello
Study officials:
affiliation: Vall d'Hebron Institute of Research
name: Irene bello, Professor
role: STUDY_CHAIR
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