Skip to content

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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06202859
Enrollment
160
Registered
2024-01-12
Start date
2022-11-01
Completion date
2025-04-30
Last updated
2024-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Transplant Failure

Keywords

respiratory physiotherapy, lung donor, improve lung donor

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.

Interventions

DEVICEMIE

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

Sponsors

Hospital Vall d'Hebron
CollaboratorOTHER
Germans Trias i Pujol Hospital
CollaboratorOTHER
Hospital Universitario Marqués de Valdecilla
CollaboratorOTHER
Vall d'Hebron Institute Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Organ donor older than 18yo

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
The changes in OxygenationTen minutes after the MIE application and 60 minutes after MIE application or national protocol aplicationThe changes of oxygenation comparing MIE to national protocol

Secondary

MeasureTime frameDescription
Rate of complications with the use of MIEDuring the intervention and 60 minutes after it.To analyse the complications associated with the use of MIE in organ donors
Number of potential lung donorsduring the recruitment timeTo analyse the increase in potential lung donors with MIE
Number of lung donorsduring the recruitment timeTo analyse the increase in lung donors with MIE

Countries

Spain

Contacts

Primary ContactIrene bello, Professor
irene.bello.rodriguez@gmail.com620664172

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026