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

Lung Diseases Clinical Trial

Official title:

A Single Center Pilot Study for Cold Oxygen Lung Preservation and Ventilation With the "Angel Cooler"

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06286319
• Other study ID #: 23-00726
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: April 2026

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: Luis Angel
• Phone: 6465019884
• Email: Luis.Angel[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Lung Diseases

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Devices Deemed "Functional"	The main outcome is a description of the function of the device (functional/non-functional).	Day 1