Brain DeathAPNEAFLOWNCT05950178
Validation of the Apnea Test Performed by High-flow Oxygen Therapy in Patients With Clinical Brain Death
A study testing Apnea test under high-flow oxygenation in people with Brain Death, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Death
- What is being tested?
- Apnea test under high-flow oxygenation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jul 2023to 7 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients in critical care with clinical brain death and potential organ and tissue donors for whom an apnea test is indicated.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Apnea Test Conducted Using High-flow Oxygen Therapy in Patients With Clinical Brain Death
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.
Read more
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)
Read the 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.
- Conditions
- Brain Death
- Being tested
- Apnea test under high-flow oxygenation
- Keywords
- Clinical brain death, Apnea test, High-flow oxygenation, Standard oxygen therapy, High-flow oxygen therapy
- Medical subject headings
- Brain Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apnea test under high-flow oxygenationDiagnostic test
Apnea test under high-flow oxygenation in patients with a confirmed clinical brain death by a standard apnea test (under standard oxygen therapy)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Apnea test under high-flow oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Determine the maximum PaCO2 value reached by all included subjects at the 10-minute mark of the apnea test with high-flow oxygen therapy
Measured: 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.
Measured: 48 hours
Recording of the PaO2/FiO2 ratio before and after each apnea test.
Measured: 48 hours
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
Measured: 48 hours
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
Measured: 48 hours
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
Measured: 48 hours
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
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start10 Jul 2023
- Primary completion7 Apr 2024
- Study completion7 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Brain DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non-randomized controlled single-center trial.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damien BARRIER, Principal investigator, CHR d'Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950178
- Sponsor's protocol ID
- CHRO-2022-10
- Acronym
- APNEAFLOW
- Status last verified
- Aug 2024
- First submitted
- 10 Jul 2023
- Last updated
- 2 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32761206Levesque 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.
PubMed 16540953Lyons 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.
PubMed 29047136Fossat 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.
PubMed 34128122Vogelmeier 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.
PubMed 28128970Wijdicks 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.
PubMed 16157923Shapiro 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.
PubMed 2516731Birks 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.
PubMed 11498147Barrier 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.
PubMed 40387463
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Apnea Test Conducted Using High-flow Oxygen Therapy in Patients With Clinical Brain Death
- ClinicalTrials.gov ID
- NCT05950178
- Acronym / sponsor ID
- APNEAFLOW / CHRO-2022-10
- Conditions
- Brain Death
- Keywords
- Clinical brain death, Apnea test, High-flow oxygenation, Standard oxygen therapy, High-flow oxygen therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 7 Apr 2024 (actual)
- Study completion
- 7 Apr 2024 (actual)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-randomized controlled single-center trial.
| Arm | Type | Receives |
|---|---|---|
| Clinical brain death | Other | Diagnostic Test: Apnea test under high-flow oxygenationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients in critical care with clinical brain death and potential organ and tissue donors for whom an apnea test is indicated.
Key exclusion criteria (10 listed)
- Minor patients.
- Person under guardianship
- Protected Majors
- Not affiliated to French social security
- Pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apnea test under high-flow oxygenationApnea test under high-flow oxygenation in patients with a confirmed clinical brain death by a standard apnea test (under standard oxygen therapy) | Diagnostic test | Clinical brain death |
Primary outcome
Percentage of patients exceeding the hypercapnia threshold
Time frame: 48 hours
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.
7 secondary outcomes
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.
Time frame: 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.
Time frame: 48 hours
Recording of the PaO2/FiO2 ratio before and after each apnea test.
Time frame: 48 hours
Recording of systolic blood pressure, measured every minute during the two apnea tests
Time frame: 48 hours
Recording of diastolic blood pressure, measured every minute during the two apnea tests
Time frame: 48 hours
Recording of heart rate,measured every minute during the two apnea tests
Time frame: 48 hours
Recording of pulse oximetry, measured every minute during the two apnea tests
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Background: PubMed 32761206Greer 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.
- Background: PubMed 16540953Levesque 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.
- Background: PubMed 29047136Lyons 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.
- Background: PubMed 34128122Fossat 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.
- Background: PubMed 28128970Vogelmeier 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.
- Background: PubMed 16157923Wijdicks 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.
- Background: PubMed 2516731Shapiro 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.
- Background: PubMed 11498147Birks 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.
- Derived from this study: PubMed 40387463Barrier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damien BARRIER principal investigator
CHR d'Orléans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apnea test under high-flow oxygenation in people with Brain Death, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients exceeding the hypercapnia threshold (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05950178, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.