Could a simple oxygen device improve brain death diagnosis?
NCT ID NCT07640009
First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time
Summary
This trial tests whether high-flow humidified oxygen (HHFO) works as well as continuous positive airway pressure (CPAP) for keeping oxygen levels stable during the apnea test, which is used to confirm brain death. The study involves 28 adult intensive care patients who meet all criteria for clinical brain death. Each patient undergoes two apnea tests—one with HHFO and one with CPAP—to compare how well each method maintains oxygenation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- High-flow humidified oxygen (HHFO)
- What this could lead to
- If HHFO works as well as CPAP, it could offer a simpler, safer way to perform apnea tests during brain death diagnosis, potentially improving organ preservation for donation.
- What could go wrong
- This is a small, early-stage study with only 28 participants, so results may not apply broadly. The trial compares two methods but does not test a new treatment or cure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adult intensive care unit patients * fulfilling all criteria for clinical brain death, for whom confirmation of the absence of spontaneous breathing requires performance of an apnea test * And for whom consent to participate in the study was sought from a trusted person or a family member Exclusion Criteria: * History of chronic obstructive pulmonary disease (COPD) classified as GOLD stage III or IV. * Current extracorporeal life support, including veno-arterial (VA) or veno-venous (VV) extracorporeal membrane oxygenation (ECMO). * PaO₂/FiO₂ ratio ≤ 150 on the most recent arterial blood gas analysis, obtained within 24 hours prior to the screening visit. * Presence of at least one clear or absolute contraindication to the procurement of at least one organ. * Presence of a high cervical spinal cord injury. * Patient in the prone position and/or with a contraindication to placement in the supine position at 30°. * Minor patient. * Protected adult under legal guardianship or curatorship. * Individual under judicial protection (safeguard of justice). * Individuals deprived of liberty. * Individual not covered by a social security or health insurance system. * Pregnant or breastfeeding woman.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chru de Tours
Tours, France
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Chu Angers
Angers, France
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Chu Orleans
Orléans, France
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Chu de Nantes
Nantes, France
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