CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
Apnea test under high-flow oxygenationother
Likely dose
Not stated in record
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Search/NCT05950178
NCT05950178N/ACompleted

Validation of Apnea Test Conducted Using High-flow Oxygen Therapy in Patients With Clinical Brain Death

Centre Hospitalier Régional d'Orléans·interventional·Posted Jul 18, 2023·Updated Aug 2, 2024

In Brief

A clinical study evaluating Apnea test under high-flow oxygenation for Brain Death. Completed, enrolled 15 participants across 1 site.

Detailed Summary

Brain death is a clinical and paraclinical diagnosis established in a known etiological context. It involves the irreversible destruction of cerebral functions in a beating-heart individual. In the context of organ and tissue donation from a critically ill patient, the clinical diagnosis of brain death is confirmed through a mandatory apnea test. This test is conducted by disconnecting the patient from the ventilator for a duration of 8 to 10 minutes. The test is considered validated when there is no spontaneous respiratory movement and the presence of hypercapnia. Hypercapnia is defined as a PaCO2 (carbon dioxide partial pressure) greater than 60 mmHg or an increase of more than 20 mmHg compared to the pre-ventilator disconnection capnia. These thresholds are meant to provide a strong stimulus to the respiratory centers, objectively confirming the absence of spontaneous ventilation. In practice, the apnea test is performed under CPAP (Continuous Positive Airway Pressure) or by administering oxygen at 6-10L/min through the endotracheal tube. High-flow oxygenation could be a simple alternative for the apnea test during the validation of the clinical diagnosis of brain death while reducing the risk of lung derecruitment and compromising organ viability and/or lung donation. However, due to the high gas flow used (60 L/min), high-flow oxygenation can lead to a "washout" effect in the anatomical dead space, which may lower the carbon dioxide partial pressure. Consequently, even in a patient in a state of brain death, where spontaneous ventilation is absent by definition, it is not certain that the carbon dioxide partial pressure will increase to the threshold of 60 mmHg or more than 20 mmHg in 10 minutes during an apnea test conducted with high-flow oxygenation. The purpose of this study is, therefore, to examine the feasibility of clinically diagnosing brain death through an apnea test performed with high-flow oxygenation. To determine whether the validation criterion which involves observing an arterial capnia \> 60 mmHg or an increase \> 20 mmHg (compared to the capnia at the beginning of the test) after 10 minutes can be achieved during an apnea test conducted under high-flow oxygen therapy in patients with clinically confirmed brain death by standard apnea test (under standard oxygen therapy)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain Death
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedJul 18, 2023
Enrollment StartJul 10, 2023
Primary CompletionApr 7, 2024
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 3.0 years ago

Interventions

Apnea test under high-flow oxygenationother

Apnea test under high-flow oxygenation in patients with a confirmed clinical brain death by a standard apnea test (under standard oxygen therapy)