Cold Oxygen Lung Preservation and Ventilation With the "Angel Cooler"

NCT ID: NCT06286319

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2026-04-30

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.

Conditions

Lung Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Explanted Lungs

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.

Group Type: EXPERIMENTAL

Angel Cooler

Intervention Type: DEVICE

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.

Interventions

Angel Cooler

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luis Angel

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Other Identifiers

23-00726

Identifier Type: -

Identifier Source: org_study_id