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Effect of High-Flow Humidified Oxygen on Ventilatory Work During the Spontaneous Breathing Trial (OTRAVAIL)

20. juli 2026 oppdatert av: University Hospital, Grenoble

Weaning from mechanical ventilation (MV) accounts for a significant portion of the total MV duration, and failure to extubate or delayed extubation increases complications (particularly Ventilator-Associated Pneumonia (VAP)) and mortality. Standard tests (T-piece, Spontaneous Ventilation with Inspiratory Assistance (SV-IA)) have not demonstrated clear superiority, and the T-piece is still widely used despite its limitations. High-flow oxygen (HFO) may reduce ventilatory work and facilitate secretion clearance; however, there is a lack of physiological data in humans with an endotracheal tube in place. This study aims to address this gap prior to a subsequent clinical evaluation.

An experimental, prospective, single-center, 3-period crossover study with randomized sequence order and single-blind design (primary endpoint assessment and statistical analysis were conducted in a blinded manner).

Studieoversikt

Status

Har ikke rekruttert ennå

Studietype

Intervensjonell

Registrering (Antatt)

30

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Adult patient, of legal age
  • On invasive mechanical ventilation for more than 48 hours
  • With at least one criterion indicating a high risk of extubation failure:

    • Age > 65 years
    • Chronic respiratory disease
    • Chronic cardiac disease
  • Capable of undergoing a mechanical ventilation weaning test ("weaning criterion"):

    • Respiratory rate < 35 bpm
    • Adequate oxygenation:

      • SpO₂ ≥ 90% with FiO₂ ≤ 40% and PEEP ≤ 8 cm H₂O
      • Or PaO₂/FiO₂ ≥ 150 with PEEP ≤ 8 cm H₂O
    • Effective cough
    • Patient is alert (RASS score -2 to +1), without sedation
    • Hemodynamically stable or on the minimum effective dose
  • Patient has an invasive arterial pressure catheter for arterial blood sampling
  • Informed consent signed by a family member
  • Patient is enrolled in or eligible for a social security program

Exclusion Criteria:

  • Resuscitation-associated neuromyopathy
  • History of neuromuscular disease
  • Admission for a neurological condition
  • Subjects currently excluded from another study,
  • Persons referred to in Articles L1121-5 through L1121-8 of the CSP (corresponding to all protected persons: pregnant women, women in labor, breastfeeding mothers, persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8, persons admitted to a health or social care facility for purposes other than research, minors, and persons subject to a legal protection order or unable to give informed consent).
  • Staff members who report to the principal investigator

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: TP/HFO/PSV
T piece follow by HFO follow by PSV
The endotracheal tube will be disconnected from the ventilator, and a T-piece (Teleflex, Trach-Vent +®) with oxygen delivery
The endotracheal tube will be connected to the pneumotachograph. The ventilator settings will be adjusted as follows: VS mode, inspiratory support at 7 cmH₂O, PEEP at 0 cmH₂O.
The endotracheal tube will be disconnected from the ventilator, and an OHD delivery device normally used for tracheostomies (Fisher & Paykel, Optiflow+®) will be connected to the pneumotachograph. The OHD flow rate will be set to 50 L/min. A Monnal T60 ventilator (Air Liquide Healthcare) will be used for OHD administration.
Annen: TP/PSV/HFO
T piece follow by PSV follow by HFO
The endotracheal tube will be disconnected from the ventilator, and a T-piece (Teleflex, Trach-Vent +®) with oxygen delivery
The endotracheal tube will be connected to the pneumotachograph. The ventilator settings will be adjusted as follows: VS mode, inspiratory support at 7 cmH₂O, PEEP at 0 cmH₂O.
The endotracheal tube will be disconnected from the ventilator, and an OHD delivery device normally used for tracheostomies (Fisher & Paykel, Optiflow+®) will be connected to the pneumotachograph. The OHD flow rate will be set to 50 L/min. A Monnal T60 ventilator (Air Liquide Healthcare) will be used for OHD administration.
Annen: PSV/HFO/TP
PSV follow by HFO follow by T piece
The endotracheal tube will be disconnected from the ventilator, and a T-piece (Teleflex, Trach-Vent +®) with oxygen delivery
The endotracheal tube will be connected to the pneumotachograph. The ventilator settings will be adjusted as follows: VS mode, inspiratory support at 7 cmH₂O, PEEP at 0 cmH₂O.
The endotracheal tube will be disconnected from the ventilator, and an OHD delivery device normally used for tracheostomies (Fisher & Paykel, Optiflow+®) will be connected to the pneumotachograph. The OHD flow rate will be set to 50 L/min. A Monnal T60 ventilator (Air Liquide Healthcare) will be used for OHD administration.
Annen: PSV/TP/HFO
PSV follow by T piece follow by HFO
The endotracheal tube will be disconnected from the ventilator, and a T-piece (Teleflex, Trach-Vent +®) with oxygen delivery
The endotracheal tube will be connected to the pneumotachograph. The ventilator settings will be adjusted as follows: VS mode, inspiratory support at 7 cmH₂O, PEEP at 0 cmH₂O.
The endotracheal tube will be disconnected from the ventilator, and an OHD delivery device normally used for tracheostomies (Fisher & Paykel, Optiflow+®) will be connected to the pneumotachograph. The OHD flow rate will be set to 50 L/min. A Monnal T60 ventilator (Air Liquide Healthcare) will be used for OHD administration.
Annen: HFO/TP/PSV
HFO follow by T piece follow by PSV
The endotracheal tube will be disconnected from the ventilator, and a T-piece (Teleflex, Trach-Vent +®) with oxygen delivery
The endotracheal tube will be connected to the pneumotachograph. The ventilator settings will be adjusted as follows: VS mode, inspiratory support at 7 cmH₂O, PEEP at 0 cmH₂O.
The endotracheal tube will be disconnected from the ventilator, and an OHD delivery device normally used for tracheostomies (Fisher & Paykel, Optiflow+®) will be connected to the pneumotachograph. The OHD flow rate will be set to 50 L/min. A Monnal T60 ventilator (Air Liquide Healthcare) will be used for OHD administration.
Annen: HFO/PSV/TP
HFO follow by PSV follow by TP
The endotracheal tube will be disconnected from the ventilator, and a T-piece (Teleflex, Trach-Vent +®) with oxygen delivery
The endotracheal tube will be connected to the pneumotachograph. The ventilator settings will be adjusted as follows: VS mode, inspiratory support at 7 cmH₂O, PEEP at 0 cmH₂O.
The endotracheal tube will be disconnected from the ventilator, and an OHD delivery device normally used for tracheostomies (Fisher & Paykel, Optiflow+®) will be connected to the pneumotachograph. The OHD flow rate will be set to 50 L/min. A Monnal T60 ventilator (Air Liquide Healthcare) will be used for OHD administration.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Respiratory work during the weaning test, defined as the energy expended to inhale and exhale a respiratory gas, measured in joules per liter per minute.
Tidsramme: 190 min
190 min

Sekundære resultatmål

Resultatmål
Tidsramme
Tidal Volume
Tidsramme: 190 min
190 min
Total Positive End-Expiratory Pressure
Tidsramme: 190 min
190 min
Respiratory Rate
Tidsramme: 190 min
190 min
minute ventilation
Tidsramme: 190 min
190 min
Ratio Respiratory rate/ Tidal volume
Tidsramme: 190 min
190 min
product pressure time
Tidsramme: 190 min
190 min
Occlusion pressure (or P 0.1)
Tidsramme: 190 min
190 min
Percentage of success on the weaning test (predefined criteria)
Tidsramme: 190 min
190 min

Andre resultatmål

Resultatmål
Tidsramme
Percentage of patients extubated following the series of weaning trials
Tidsramme: 190 min
190 min
Percentage of reintubations within 48 hours after extubation
Tidsramme: 52 hours
52 hours

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. januar 2027

Primær fullføring (Antatt)

1. januar 2027

Studiet fullført (Antatt)

1. januar 2027

Datoer for studieregistrering

Først innsendt

20. juli 2026

Først innsendt som oppfylte QC-kriteriene

20. juli 2026

Først lagt ut (Faktiske)

24. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 38RC25.0307

Legemiddel- og utstyrsinformasjon, studiedokumenter

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Nei

produkt produsert i og eksportert fra USA

Nei

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