Lung Diseases
Conditions
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.
Interventions
Device that provides cooled oxygen (between 4-8°C) directly to the lung airways along with external cooling to lung surfaces using cold preservation solutions.
Sponsors
Study design
Eligibility
Inclusion criteria
* Age at least 18 years * Subjects who have signed Universal Consent are eligible for participation. * Subjects willing to sign the Universal Consent for the use of their lungs in this study.
Exclusion criteria
• Explanted lungs of those who have not signed the Universal Consent (UC) or who have declined participation in the UC will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Devices Deemed Functional | Day 1 | The main outcome is a description of the function of the device (functional/non-functional). |
Countries
United States