Efficacy of High-Flow Humidified Oxygen (HFHO) in Apneic Oxygenation for Apnea Testing: A Comparison With Continuous Positive Airway Pressure (CPAP) (APNEAFLO2W)
Efficacy of High-Flow Humidified Oxygen in Apneic Oxygenation During Apnea Testing Compared With Continuous Positive Airway Pressure: A Randomized Multicenter Crossover Trial
Brain death (BD) is characterized by a severe brain injury resulting in irreversible loss of all brain and brainstem functions, while other organs may remain viable. The diagnosis of BD is based on the presence of coma, absence of brainstem reflexes, and absence of spontaneous breathing confirmed by an apnea test. In France, the apnea test is mandatory prior to organ procurement. The apnea test aims to demonstrate that hypercapnia, a strong ventilatory stimulus, does not induce any respiratory movements.
In current practice, the apnea test is performed by disconnecting the patient from mechanical ventilation for 8-10 minutes while administering oxygen. Oxygenation strategies during apnea vary across French centers. Although the use of continuous positive airway pressure (CPAP) is recommended, a substantial proportion of tests are still performed without positive end-expiratory pressure (PEEP) effect, using either an open T-piece or an intratracheal oxygen catheter. These methods are associated with a higher risk of complications, such as hypoxemia, and potential adverse effects on organ function, which is particularly relevant in the context of organ donation.
Humidified high-flow oxygen (HHFO), delivered via a specialized device connected to the endotracheal tube, provides high flow rates (up to 60 L/min), allows precise adjustment of the fraction of inspired oxygen (FiO₂ up to 1.0), and generates a minimal PEEP effect. HHFO is routinely used in intensive care units. While its feasibility during apnea testing has been reported, its efficacy during BD diagnosis has not been well evaluated.
Preliminary observations in intensive care patients with clinical brain death suggest that HHFO can be safely used during the apnea test, allowing achievement of hypercapnia and confirmation of absence of spontaneous respiration while maintaining better oxygenation compared with conventional oxygen delivery via an open T-piece.
This study aims to evaluate the efficacy of HHFO for apneic oxygenation during the apnea test, in comparison with the recommended method using CPAP.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
The study strategy is based on performing two consecutive apnea tests in patients with clinical brain death, conducted in a randomized order. Only patients in whom the first apnea test confirms the absence of spontaneous breathing will proceed to the second apnea test. Consistency of clinical brain death at the end of the first apnea test are defined by the absence of any respiratory movement and the presence of either an arterial partial pressure of carbon dioxide (PaCO₂) ≥ 60 mmHg or an increase in PaCO₂ > 20 mmHg compared with the PaCO₂ measured at the end of the preoxygenation period.
Each of the two apnea tests will be preceded by a standardized 15-minute preoxygenation period using assisted controlled ventilation with a tidal volume of 6mL/kg of predicted body weight.
The two consecutive apnea tests will be performed in randomized order under CPAP and under HHFO with standardized parameters.
As per routine clinical practice, an arterial blood gas sample will be obtained before disconnection from the ventilator at the end of the preoxygenation period to confirm normocapnia, defined as 35 mmHg ≤ PaCO₂ ≤ 45 mmHg. A second arterial blood gas sample will be obtained at the end of the apnea test, prior to reconnection to the ventilator, to measure PaCO₂ and arterial partial pressure of oxygen (PaO₂).
Specifically for the purposes of the study, during each apnea test, the investigator will perform arterial blood gas sampling every 2 minutes to measure PaO₂, PaCO₂, and pH. At the same time points, arterial blood pressure, heart rate, pulse oximetry, and catecholamine infusion doses will be recorded.
In addition to these measurements required to meet the study objectives, demographic and clinical data will be collected primarily from the medical records to characterize the study population.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Angers, Frankrike
- CHU Angers
-
Kontakt:
- Aurore ARMAND, MD
- E-post: auarmand@chu-angers.fr
-
Huvudutredare:
- Aurore ARMAND, MD
-
Nantes, Frankrike
- CHU de Nantes
-
Huvudutredare:
- Jean-Baptiste Lascarrou, MD
-
Kontakt:
- jaen-Baptiste LASCARROU, MD
- E-post: jeanbaptiste.lascarrou@chu-nantes.fr
-
Orléans, Frankrike
- Chu Orleans
-
Huvudutredare:
- Damien BARRIER
-
Kontakt:
- Damien BARRIER
- E-post: damien.barrier@chu-orleans.fr
-
Tours, Frankrike
- CHRU de Tours
-
Huvudutredare:
- Sophie JACQUIER, MD
-
Kontakt:
- Sophie JACQUIER, MD
- E-post: s.jacquier@chu-tours.fr
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Arm HHFO in first
HHFO in first: in this arm, the first of the two consecutive apnea tests is performed under HHFO, followed by a second apnea test under CPAP.
|
For each 10-minute apnea test, regardless of the oxygenation device used, arterial blood gas will be analysed and heart rate, arterial pressure, and pulse oximetry will be recorded in 2-minute intervals.
For each 10-minute apnea test, regardless of the oxygenation device used, arterial blood gas will be analysed and heart rate, arterial pressure, and pulse oximetry will be recorded in 2-minute intervals.
|
|
Experimentell: Arm CPAP in first.
CPAP in first: in this arm, the first of the two consecutive apnea tests is performed under CPAP, followed by a second apnea test under HHFO.
|
For each 10-minute apnea test, regardless of the oxygenation device used, arterial blood gas will be analysed and heart rate, arterial pressure, and pulse oximetry will be recorded in 2-minute intervals.
For each 10-minute apnea test, regardless of the oxygenation device used, arterial blood gas will be analysed and heart rate, arterial pressure, and pulse oximetry will be recorded in 2-minute intervals.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in PaO₂ (mmHg) between the beginning and the end of an apnea test under HHFO and CPAP
Tidsram: From ventilator disconnection to 10th minute of the apnea test
|
To demonstrate the non-inferiority of humidified high-flow oxygen compared to continuous positive airway pressure in apneic oxygenation for apnea testing.
|
From ventilator disconnection to 10th minute of the apnea test
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Evolution of arterial blood PaO2 parameters during the apnea test under HHFO and the apnea test with CPAP
Tidsram: At 2-minute intervals from ventilator disconnection to the 10th minute of each apnea test
|
Recording of PaO2 values measured in 2-minute intervals during the apnea test under HHFO and apnea test with CPAP
|
At 2-minute intervals from ventilator disconnection to the 10th minute of each apnea test
|
|
Evolution of arterial blood PaCO2 parameters during the apnea test under HHFO and the apnea test with CPAP
Tidsram: At 2-minute intervals from ventilator disconnection to the 10th minute of each apnea test
|
Recording of PaCO2 values measured in 2-minute intervals during the apnea test under HHFO and apnea test with CPAP
|
At 2-minute intervals from ventilator disconnection to the 10th minute of each apnea test
|
|
Evolution of arterial blood pH parameters during the apnea test under HHFO and the apnea test with CPAP
Tidsram: At 2-minute intervals from ventilator disconnection to the 10th minute of each apnea test
|
Recording of pH values measured in 2-minute intervals during the apnea test under HHFO and apnea test with CPAP
|
At 2-minute intervals from ventilator disconnection to the 10th minute of each apnea test
|
|
Evolution of arterial blood pressure during the apnea test under HHFO and the apnea test with CPAP
Tidsram: At 2-minute intervals from ventilator disconnection to the 10th minute of each apnea test
|
Recording of arterial blood pressure measured in 2-minute intervals during the apnea test under HHFO and with CPAP.
|
At 2-minute intervals from ventilator disconnection to the 10th minute of each apnea test
|
|
Evolution of heart rate during the apnea test under HHFO and the apnea test with CPAP
Tidsram: At 2-minute intervals from ventilator disconnection to the 10th minute of each apnea test
|
Recording of heart rate measured in 2-minute intervals during the apnea test under HHFO and with CPAP.
|
At 2-minute intervals from ventilator disconnection to the 10th minute of each apnea test
|
|
Evolution of pulse oximetry during the apnea test under HHFO and the apnea test with CPAP
Tidsram: At 2-minute intervals from ventilator disconnection to the 10th minute of each apnea test
|
Recording of pulse oximetry measured in 2-minute intervals during the apnea test under HHFO and with CPAP.
|
At 2-minute intervals from ventilator disconnection to the 10th minute of each apnea test
|
|
Time required to reach the hypercapnia thresholds necessary to confirm brain death during an apnea test under HHFO and with CPAP
Tidsram: From ventilator disconnection until the hypercapnia threshold is reached
|
Time required to exceed 60mmHg of PaCO2 or for which PaCO2 increases by more than 20mmHg compared to the PaCO2 before disconnection during an apnea test under HHFO and with CPAP
|
From ventilator disconnection until the hypercapnia threshold is reached
|
|
Occurrence of apnea test interruptions during HHFO and CPAP.
Tidsram: From ventilator disconnection until apnea test termination due to intolerance
|
Documentation of apnea test interruptions under HHFO and CPAP.
|
From ventilator disconnection until apnea test termination due to intolerance
|
|
Nurse-rated numeric scale evaluations of Humidified High Flow Oxygen and Continuous Positive Airway Pressure use for each enrolled patient
Tidsram: Within 1 hour after each apnea test.
|
Nurse-rated ease of use will be assessed using a 4-point numeric scale (range: 0-3).
The minimum score is 0 and the maximum score is 3.
A score of 0 corresponds to very difficult use, and a score of 3 corresponds to very easy use.
Higher scores indicate greater ease of use
|
Within 1 hour after each apnea test.
|
Samarbetspartners och utredare
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CHUO-2025-05
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .