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

Primary Purpose

Brain Death

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Apnea test under high-flow oxygenation
Sponsored by
Centre Hospitalier Régional d'Orléans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Death focused on measuring Clinical brain death, Apnea test, High-flow oxygenation, Standard oxygen therapy, High-flow oxygen therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHR d'ORLEANSRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Clinical brain death

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Determine the maximum PaCO2 value reached by all included subjects at the 10-minute mark of the apnea test with high-flow oxygen therapy
Recording of PaO2 and PaCO2 values measured in 2-minute intervals during the standard apnea test and apnea test under high-flow oxygen therapy.
Recording of the PaO2/FiO2 ratio before and after each apnea test.
Recording of systolic blood pressure, measured every minute during the two apnea tests
Describe the evolution of hemodynamic parameters during the standard apnea test and the apnea test with high-flow oxygen therapy
Recording of diastolic blood pressure, measured every minute during the two apnea tests
Describe the evolution of hemodynamic parameters during the standard apnea test and the apnea test with high-flow oxygen therapy
Recording of heart rate,measured every minute during the two apnea tests
Describe the evolution of hemodynamic parameters during the standard apnea test and the apnea test with high-flow oxygen therapy
Recording of pulse oximetry, measured every minute during the two apnea tests
Describe the evolution of hemodynamic parameters during the standard apnea test and the apnea test with high-flow oxygen therapy

Full Information

First Posted
July 10, 2023
Last Updated
July 19, 2023
Sponsor
Centre Hospitalier Régional d'Orléans
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1. Study Identification

Unique Protocol Identification Number
NCT05950178
Brief Title
Validation of the Apnea Test Performed by High-flow Oxygen Therapy in Patients With Clinical Brain Death
Acronym
APNEAFLOW
Official Title
Validation of Apnea Test Conducted Using High-flow Oxygen Therapy in Patients With Clinical Brain Death
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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)
Detailed Description
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. After a standardized preoxygenation, the 1st apnea test will be performed under standard oxygen therapy through the endotracheal tube (flow at 8L/min) for 10 minutes. An arterial blood gas sampling will be sampled every 2 minutes during the1st apnea test. The confirmation of clinical brain death by validating the apnea test under standard oxygen therapy will be done if the following two conditions are met: 1) absence of a spontaneous respiratory movements AND 2) an arterial capnia > 60 mmHg or an increase > 20 mmHg (compared to the capnia at the end of preoxygenation). Then the patient will be reconnected to the ventilator for 15 minutes. A second standardized preoxygenation will be performed before the 2nd apnea test. The second apnea test will be performed under high-flow oxygen therapy through the endotracheal tube (flow at 50L/min, FiO2 100%) for 10 minutes. An arterial blood gas sampling will be sampled every 2 minutes during the1st apnea test. Then the patient will be reconnected to the ventilator with the same settings before the start of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Death
Keywords
Clinical brain death, Apnea test, High-flow oxygenation, Standard oxygen therapy, High-flow oxygen therapy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Non-randomized controlled single-center trial.
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clinical brain death
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Apnea test under high-flow oxygenation
Intervention Description
Apnea test under high-flow oxygenation in patients with a confirmed clinical brain death by a standard apnea test (under standard oxygen therapy)
Primary Outcome Measure Information:
Title
Percentage of patients exceeding the hypercapnia threshold
Description
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.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
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.
Description
Determine the maximum PaCO2 value reached by all included subjects at the 10-minute mark of the apnea test with high-flow oxygen therapy
Time Frame
48 hours
Title
Recording of PaO2 and PaCO2 values measured in 2-minute intervals during the standard apnea test and apnea test under high-flow oxygen therapy.
Time Frame
48 hours
Title
Recording of the PaO2/FiO2 ratio before and after each apnea test.
Time Frame
48 hours
Title
Recording of systolic blood pressure, measured every minute during the two apnea tests
Description
Describe the evolution of hemodynamic parameters during the standard apnea test and the apnea test with high-flow oxygen therapy
Time Frame
48 hours
Title
Recording of diastolic blood pressure, measured every minute during the two apnea tests
Description
Describe the evolution of hemodynamic parameters during the standard apnea test and the apnea test with high-flow oxygen therapy
Time Frame
48 hours
Title
Recording of heart rate,measured every minute during the two apnea tests
Description
Describe the evolution of hemodynamic parameters during the standard apnea test and the apnea test with high-flow oxygen therapy
Time Frame
48 hours
Title
Recording of pulse oximetry, measured every minute during the two apnea tests
Description
Describe the evolution of hemodynamic parameters during the standard apnea test and the apnea test with high-flow oxygen therapy
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients in critical care with clinical brain death and potential organ and tissue donors for whom an apnea test is indicated. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ELodie POUGOUE TOUKO
Phone
+33238744086
Email
elodie.pougoue-touko@chr-orleans.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damien BARRIER
Organizational Affiliation
CHR d'Orléans
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR d'ORLEANS
City
Orléans
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien BARRIER
Email
damien.barrier@chr-orleans.fr
First Name & Middle Initial & Last Name & Degree
Damien BARRIER

12. IPD Sharing Statement

Citations:
PubMed Identifier
32761206
Citation
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.
Results Reference
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16540953
Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
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Citation
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.
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Citation
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.
Results Reference
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Citation
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Validation of the Apnea Test Performed by High-flow Oxygen Therapy in Patients With Clinical Brain Death

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