Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06202859
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2023-10-23
Brief Title:
Respiratory Physiotherapy as a Tool to Increase the Number of Solid Organ Donors
Sponsor:
Vall dHebron Institute Research
Organization:
Vall dHebron Institute Research
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 dHebron 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-ECough 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-ECough 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:
None
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?:
None