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

20 de julho de 2026 atualizado por: 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).

Visão geral do estudo

Status

Ainda não está recrutando

Tipo de estudo

Intervencional

Inscrição (Estimado)

30

Estágio

  • Não aplicável

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Outro: 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.
Outro: 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.
Outro: 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.
Outro: 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.
Outro: 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.
Outro: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
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.
Prazo: 190 min
190 min

Medidas de resultados secundários

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

Outras medidas de resultado

Medida de resultado
Prazo
Percentage of patients extubated following the series of weaning trials
Prazo: 190 min
190 min
Percentage of reintubations within 48 hours after extubation
Prazo: 52 hours
52 hours

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de janeiro de 2027

Conclusão Primária (Estimado)

1 de janeiro de 2027

Conclusão do estudo (Estimado)

1 de janeiro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

20 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de julho de 2026

Primeira postagem (Real)

24 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

20 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 38RC25.0307

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

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