Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07640009
NA

Efficacy of High-Flow Humidified Oxygen (HFHO) in Apneic Oxygenation for Apnea Testing: A Comparison With Continuous Positive Airway Pressure (CPAP)

Sponsor: Centre Hospitalier Régional d'Orléans

View on ClinicalTrials.gov

Summary

Brain death (BD) is characterized by a severe brain injury resulting in irreversible loss of all brain and brainstem functions, while other organs may remain viable. The diagnosis of BD is based on the presence of coma, absence of brainstem reflexes, and absence of spontaneous breathing confirmed by an apnea test. In France, the apnea test is mandatory prior to organ procurement. The apnea test aims to demonstrate that hypercapnia, a strong ventilatory stimulus, does not induce any respiratory movements. In current practice, the apnea test is performed by disconnecting the patient from mechanical ventilation for 8-10 minutes while administering oxygen. Oxygenation strategies during apnea vary across French centers. Although the use of continuous positive airway pressure (CPAP) is recommended, a substantial proportion of tests are still performed without positive end-expiratory pressure (PEEP) effect, using either an open T-piece or an intratracheal oxygen catheter. These methods are associated with a higher risk of complications, such as hypoxemia, and potential adverse effects on organ function, which is particularly relevant in the context of organ donation. Humidified high-flow oxygen (HHFO), delivered via a specialized device connected to the endotracheal tube, provides high flow rates (up to 60 L/min), allows precise adjustment of the fraction of inspired oxygen (FiO₂ up to 1.0), and generates a minimal PEEP effect. HHFO is routinely used in intensive care units. While its feasibility during apnea testing has been reported, its efficacy during BD diagnosis has not been well evaluated. Preliminary observations in intensive care patients with clinical brain death suggest that HHFO can be safely used during the apnea test, allowing achievement of hypercapnia and confirmation of absence of spontaneous respiration while maintaining better oxygenation compared with conventional oxygen delivery via an open T-piece. This study aims to evaluate the efficacy of HHFO for apneic oxygenation during the apnea test, in comparison with the recommended method using CPAP.

Official title: Efficacy of High-Flow Humidified Oxygen in Apneic Oxygenation During Apnea Testing Compared With Continuous Positive Airway Pressure: A Randomized Multicenter Crossover Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2026-09-15

Completion Date

2028-09-15

Last Updated

2026-07-10

Healthy Volunteers

No

Conditions

Interventions

OTHER

Apnea test under HHFO followed by an apnea test under CPAP.

For each 10-minute apnea test, regardless of the oxygenation device used, arterial blood gas will be analysed and heart rate, arterial pressure, and pulse oximetry will be recorded in 2-minute intervals.

OTHER

Apnea test under CPAP followed by an apnea test under HHFO.

For each 10-minute apnea test, regardless of the oxygenation device used, arterial blood gas will be analysed and heart rate, arterial pressure, and pulse oximetry will be recorded in 2-minute intervals.

Locations (4)

Chu Angers

Angers, France

Chu de Nantes

Nantes, France

Chu Orleans

Orléans, France

Chru de Tours

Tours, France