MedTrace Logo

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

NCT06202859 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-01-12

No results posted yet for this study

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.

Conditions

  • Lung Transplant Failure

Interventions

DEVICE

MIE

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

Sponsors & Collaborators

  • Hospital Vall d'Hebron

    collaborator OTHER

  • Germans Trias i Pujol Hospital

    collaborator OTHER

  • Hospital Universitario Marqués de Valdecilla

    collaborator OTHER

  • Vall d'Hebron Institute Research

    lead OTHER

Principal Investigators

  • Irene bello, Professor · Vall d'Hebron Institute of Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06202859 on ClinicalTrials.gov