Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06286319
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-02-22
Brief Title:
Cold Oxygen Lung Preservation and Ventilation With the Angel Cooler
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
A Single Center Pilot Study for Cold Oxygen Lung Preservation and Ventilation With the Angel Cooler
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 objective of this feasibility study is to evaluate continuous temperature monitoring oxygen O2 concentration and ventilation with positive end expiratory pressure PEEP to keep lungs cooled at 4-8 degrees Celsius with continuous O2 concentration of 100 and inflated with a PEEP of 8-10 during the entire cold ischemic period
Detailed Description:
The Angel Lung Cooler is a lung preservation method for transplantation The device has temperature and airway pressure sensors that assess the oxygen temperature in the airways to confirm during the entire preservation time that desired airway temperatures between 8 and 10 oC and mean airway pressure to keep the lungs inflated during transportation is optimized
For the purposes of the trial the Angel Cooler will be in the operating room at time of transplant when both of the lungs are explanted The explanted lungs those removed and not the donor lungs will be connected to the cooler to determine inflation and temperature changes of the lungs This procedure will take approximately 5 - 20 minutes The lungs will then be disconnected from the cooler and then returned to the back table for transport to the Pathology department As part of standard procedures the lungs remain in the Operating room for a few hours before they are transported to the Pathology department
For the purposes of the trial the Angel Cooler will be in the operating room at time of transplant when both of the lungs are explanted The explanted lungs those removed and not the donor lungs will be connected to the cooler to determine inflation and temperature changes of the lungs This procedure will take approximately 5 - 20 minutes The lungs will then be disconnected from the cooler and then returned to the back table for transport to the Pathology department As part of standard procedures the lungs remain in the Operating room for a few hours before they are transported to the Pathology department
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