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

NCT06286319 | Withdrawn

• 1 other identifier: 23-00726
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Diseases

Outcome Measures

Primary Outcomes (1)

• Proportion of Devices Deemed "Functional"

  The main outcome is a description of the function of the device (functional/non-functional).

  Day 1

Study Arms (1)

Explanted Lungs

EXPERIMENTAL

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.

Device: Angel Cooler

Interventions

Angel Cooler 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.

Explanted Lungs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Explanted lungs of those who have not signed the Universal Consent (UC) or who have declined participation in the UC will be excluded.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Luis Angel

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: January 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)