Angel Cooler for Lung Disease

Overseen By Luis Angel

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Declined universal consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Trial Summary

What is the purpose of this trial?

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.

Research Team

Luis Angel, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for individuals with lung disease. Specific eligibility criteria are not provided, so it's important to contact the study organizers for detailed information on who can participate.

Inclusion Criteria

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Procedure

The Angel Cooler is used to preserve explanted lungs by maintaining them at a specific temperature and pressure for 15-20 minutes.

15-20 minutes

1 visit (in-person)

Follow-up

Participants are monitored for the functionality of the device on Day 1.

1 day

Treatment Details

Interventions

• Angel Cooler

Trial Overview The 'Angel Cooler' system is being tested to see if it can effectively monitor temperature and oxygen levels while keeping donated lungs cool and ventilated before transplant.

Participant Groups

Group I: Explanted Lungs Experimental Treatment 1 Intervention

After the lungs are explanted from the recipient donor, they will be connected to the "Angel Cooler" via a tracheostomy tube or special adaptor to assess the function of this device in providing cooling oxygen and positive pressure to keep the lungs inflated while on the back table. The lungs will be hooked up to the cooling machine for 15-20 minutes. During this time, investigators will monitor the airway temperature, pressure and oxygen concentration continuously during the entire preservation time. Once these measures are obtained and synced to a corresponding computer, investigators will then disconnect the lungs from the device and continue the standard procedure of sending them to pathology where they will be discarded per usual in lung transplantation.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+