Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Efficacy of High-Flow Humidified Oxygen (HFHO) in Apneic Oxygenation for Apnea Testing: A Comparison With Continuous Positive Airway Pressure (CPAP) (APNEAFLO2W)

5 giugno 2026 aggiornato da: Centre Hospitalier Régional d'Orléans

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

28

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: Apnea test under HHFO followed by an 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.
Altro: Apnea test under CPAP followed by an 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.
Sperimentale: 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.
Altro: Apnea test under HHFO followed by an 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.
Altro: Apnea test under CPAP followed by an 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in PaO₂ (mmHg) between the beginning and the end of an apnea test under HHFO and CPAP
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Evolution of arterial blood PaO2 parameters during the apnea test under HHFO and the apnea test with CPAP
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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
Ease of use of HHFO and CPAP for conducting an apnea test
Lasso di tempo: Within 1 hour after each apnea test.
Nurse-rated numeric scale evaluations of HHFO and CPAP use for each enrolled patient.
Within 1 hour after each apnea test.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Centre Hospitalier Régional d'Orléans

Collaboratori

Fisher and Paykel Healthcare

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 settembre 2026

Completamento primario (Stimato)

15 settembre 2028

Completamento dello studio (Stimato)

15 settembre 2028

Date di iscrizione allo studio

Primo inviato

5 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 giugno 2026

Primo Inserito (Effettivo)

10 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CHUO-2025-05

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Morte, cervello

Prove cliniche su Apnea test under HHFO followed by an apnea test under CPAP.

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Türkiye

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi