An interventional study of MIE in Lung Transplant Failure, sponsored by Vall d'Hebron Institute Research. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-12.
Sponsored by Vall d'Hebron Institute Research · Not applicable, Interventional, and Treatment
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.
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.
Vall d'Hebron Institute Research is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
* 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
Maintained following national guidelines.
Device: MIE
Two sequences separated for 1 min of 6 cycles each of MI-E(Cough Assist E70, Respironics Philips.
The changes in Oxygenation
The changes of oxygenation comparing MIE to national protocol
Time frame: Ten minutes after the MIE application and 60 minutes after MIE application or national protocol aplication
Rate of complications with the use of MIE
To analyse the complications associated with the use of MIE in organ donors
Time frame: During the intervention and 60 minutes after it.
Number of potential lung donors
To analyse the increase in potential lung donors with MIE
Time frame: during the recruitment time
Number of lung donors
To analyse the increase in lung donors with MIE
Time frame: during the recruitment time
Plan to share: Yes — All IPD that underlie results in a publication
Supporting information: Study protocol, Csr
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Vall d'Hebron Institute Research