Validation of the Apnea Test Performed by High-flow Oxygen Therapy in Patients With Clinical Brain Death

NCT05950178 | Completed

• 1 other identifier: CHRO-2022-10
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Brain Death

Keywords

Clinical brain death; Apnea test; High-flow oxygenation; Standard oxygen therapy; High-flow oxygen therapy

Outcome Measures

Primary Outcomes (1)

• Percentage of patients exceeding the hypercapnia threshold

  Percentage of patients exceeding the hypercapnia threshold after an apnea test conducted under high-flow oxygen therapy among patients who have already been validated for the apnea test under standard oxygen therapy.

  48 hours

Secondary Outcomes (7)

• Time required after ventilator disconnection to exceed 60mmHg of PaCO2 or for which PaCO2 increases by more than 20mmHg compared to the PaCO2 before disconnection.

  48 hours

• Recording of PaO2 and PaCO2 values measured in 2-minute intervals during the standard apnea test and apnea test under high-flow oxygen therapy.

  48 hours

• Recording of the PaO2/FiO2 ratio before and after each apnea test.

  48 hours

• Recording of systolic blood pressure, measured every minute during the two apnea tests

  48 hours

• Recording of diastolic blood pressure, measured every minute during the two apnea tests

  48 hours

Study Arms (1)

Clinical brain death

OTHER

The protocol is based on performing two consecutive apnea tests on a patient in clinical brain death in intensive care unit. The first apnea test will be conducted under standard oxygen therapy and confirms clinical brain death (standard procedure). The second apnea test (for the study) will be conducted under high-flow oxygen therapy. Only patients whose apnea test is initially validated under standard oxygen therapy will have the second apnea test under high-flow oxygen therapy.

Diagnostic Test: Apnea test under high-flow oxygenation

Interventions

Apnea test under high-flow oxygenation DIAGNOSTIC_TEST

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

Clinical brain death

Eligibility Criteria

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

You may qualify if:

• All patients in critical care with clinical brain death and potential organ and tissue donors for whom an apnea test is indicated.

You may not qualify if:

• Minor patients.
• Person under guardianship
• Protected Majors
• Not affiliated to French social security
• Pregnant women.
• Patients with a history of Chronic Obstructive Pulmonary Disease with a GOLD score of III or IV.
• Patients with at least one absolute contraindication to organ donation.
• Patients whose relatives have spontaneously expressed the patient's refusal to donate organs for therapeutic purposes.
• Patients on VA ECMO and, in general, any patient with a contraindication to performing the apnea test (DV, significant hemodynamic instability...).
• Patients whose relatives have refused the patient's participation in the study.

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

CHR d'ORLEANS

Orléans, France

Location

Related Publications (9)

• Greer DM, Shemie SD, Lewis A, Torrance S, Varelas P, Goldenberg FD, Bernat JL, Souter M, Topcuoglu MA, Alexandrov AW, Baldisseri M, Bleck T, Citerio G, Dawson R, Hoppe A, Jacobe S, Manara A, Nakagawa TA, Pope TM, Silvester W, Thomson D, Al Rahma H, Badenes R, Baker AJ, Cerny V, Chang C, Chang TR, Gnedovskaya E, Han MK, Honeybul S, Jimenez E, Kuroda Y, Liu G, Mallick UK, Marquevich V, Mejia-Mantilla J, Piradov M, Quayyum S, Shrestha GS, Su YY, Timmons SD, Teitelbaum J, Videtta W, Zirpe K, Sung G. Determination of Brain Death/Death by Neurologic Criteria: The World Brain Death Project. JAMA. 2020 Sep 15;324(11):1078-1097. doi: 10.1001/jama.2020.11586.

  PMID: 32761206 BACKGROUND

• Levesque S, Lessard MR, Nicole PC, Langevin S, LeBlanc F, Lauzier F, Brochu JG. Efficacy of a T-piece system and a continuous positive airway pressure system for apnea testing in the diagnosis of brain death. Crit Care Med. 2006 Aug;34(8):2213-6. doi: 10.1097/01.CCM.0000215114.46127.DA.

  PMID: 16540953 BACKGROUND

• Lyons C, Callaghan M. Apnoeic oxygenation with high-flow nasal oxygen for laryngeal surgery: a case series. Anaesthesia. 2017 Nov;72(11):1379-1387. doi: 10.1111/anae.14036.

  PMID: 29047136 BACKGROUND

• Fossat G, Nay MA, Jacquier S, Desmalles E, Boulain T. High-flow oxygen during spontaneous breathing trial for patients at high risk of weaning failure. Intensive Care Med. 2021 Aug;47(8):916-917. doi: 10.1007/s00134-021-06450-x. Epub 2021 Jun 14. No abstract available.

  PMID: 34128122 BACKGROUND

• Vogelmeier CF, Criner GJ, Martinez FJ, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, Chen R, Decramer M, Fabbri LM, Frith P, Halpin DM, Lopez Varela MV, Nishimura M, Roche N, Rodriguez-Roisin R, Sin DD, Singh D, Stockley R, Vestbo J, Wedzicha JA, Agusti A. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report. GOLD Executive Summary. Am J Respir Crit Care Med. 2017 Mar 1;195(5):557-582. doi: 10.1164/rccm.201701-0218PP.

  PMID: 28128970 BACKGROUND

• Wijdicks EF, Manno EM, Holets SR. Ventilator self-cycling may falsely suggest patient effort during brain death determination. Neurology. 2005 Sep 13;65(5):774. doi: 10.1212/01.wnl.0000174626.94197.62. No abstract available.

  PMID: 16157923 BACKGROUND

• Shapiro BA. The apnea-PaCO2 relationship: some clinical and medico-legal considerations. J Clin Anesth. 1989;1(5):323-7. doi: 10.1016/0952-8180(89)90069-x. No abstract available.

  PMID: 2516731 BACKGROUND

• Birks EJ, Burton PB, Owen VJ, Latif N, Nyawo B, Yacoub MH. Molecular and cellular mechanisms of donor heart dysfunction. Transplant Proc. 2001 Aug;33(5):2749-51. doi: 10.1016/s0041-1345(01)02178-9. No abstract available.

  PMID: 11498147 BACKGROUND

• Barrier D, Vanacker L, Muller G, Szychowiak P, Bretagnol A, Levebvre I, Narcisse E, Pascot L, Boulain T, Nay MA. Feasibility of High-Flow Oxygen Therapy in Apnea Testing for Brain Death Diagnosis. Crit Care Med. 2025 Jul 1;53(7):e1449-e1456. doi: 10.1097/CCM.0000000000006717. Epub 2025 May 19.

  PMID: 40387463 DERIVED

MeSH Terms

Conditions

Brain Death

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Coma; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Damien BARRIER

  CHR d'Orléans

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Non-randomized controlled single-center trial.

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 18, 2023
• Study Start: July 10, 2023
• Primary Completion: April 7, 2024
• Study Completion: April 7, 2024
• Last Updated: August 2, 2024

Record last verified: 2024-08

Locations

FR (1)