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Clinical Trials/NCT06202859
NCT06202859
Recruiting
N/A

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

Vall d'Hebron Institute Research1 site in 1 country160 target enrollmentNovember 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Lung Transplant Failure
Sponsor
Vall d'Hebron Institute Research
Enrollment
160
Locations
1
Primary Endpoint
The changes in Oxygenation
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2022
End Date
April 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Irene Bello

Professor

Institut d'Investigacions Biomèdiques August Pi i Sunyer

Eligibility Criteria

Inclusion Criteria

  • Organ donor older than 18yo

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Rate of complications with the use of MIE(During the intervention and 60 minutes after it.)
  • Number of lung donors(during the recruitment time)
  • Number of potential lung donors(during the recruitment time)

Study Sites (1)

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