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

Not Applicable

Recruiting

• Conditions: Lung Transplant Failure
• Interventions: Device: MIE

• Registration Number: NCT06202859
• Lead Sponsor: Vall d'Hebron Institute Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-01
• Study First Submitted: 2023-10-23
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-09
• Last Update Submitted: 2024-01-09
• Study First Posted: 2024-01-12
• Last Update Posted: 2024-01-12
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Organ donor older than 18yo

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MIE group	MIE	* Manual techniques of secretion drainage * Two sequences separated for 1 min of 6 cycles each of MI-E(Cough Assist E70, Respironics Philips.
Control group	MIE	Maintained following national guidelines.

Primary Outcome Measures

Name	Time	Method
The changes in Oxygenation	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 Outcome Measures

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

Trial Locations

Locations (1)

Irene bello; 🇪🇸 Barcelona, Spain