Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-26 @ 4:22 AM
Study NCT ID:
NCT06202859
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2023-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Respiratory Physiotherapy as a Tool to Increase the Number of Solid Organ Donors
Sponsor:
Vall d'Hebron Institute Research
Organization:
Study Overview
Official Title:
Respiratory Physiotherapy as a Tool to Increase the Number of Solid Organ Donors
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: