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

January 9, 2024 updated by: Irene Bello, Vall d'Hebron Institute Research

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Organ donor older than 18yo

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MIE group
  • Manual techniques of secretion drainage
  • Two sequences separated for 1 min of 6 cycles each of MI-E(Cough Assist E70, Respironics Philips.
Device: MIE
Two sequences separated for 1 min of 6 cycles each of MI-E(Cough Assist E70, Respironics Philips.
Active Comparator: Control group
Maintained following national guidelines.
Device: MIE
Two sequences separated for 1 min of 6 cycles each of MI-E(Cough Assist E70, Respironics Philips.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes in Oxygenation
Time Frame: 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
Ten minutes after the MIE application and 60 minutes after MIE application or national protocol aplication

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of complications with the use of MIE
Time Frame: During the intervention and 60 minutes after it.
To analyse the complications associated with the use of MIE in organ donors
During the intervention and 60 minutes after it.
Number of potential lung donors
Time Frame: during the recruitment time
To analyse the increase in potential lung donors with MIE
during the recruitment time
Number of lung donors
Time Frame: during the recruitment time
To analyse the increase in lung donors with MIE
during the recruitment time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vall d'Hebron Institute Research

Collaborators

Germans Trias i Pujol Hospital
Hospital Vall d'Hebron
Hospital Universitario Marqués de Valdecilla

Investigators

  • Study Chair: Irene bello, Professor, Vall d'Hebron Institute of Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

October 23, 2023

First Submitted That Met QC Criteria

January 9, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MIE-don study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication

IPD Sharing Time Frame

IPD will become available since the publications during 3 years

IPD Sharing Access Criteria

IPD will be available for researchers involved in organ donation, respiratory physiotherapy or lung transplantation who asked by email to main researcher.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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