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NCT Number: NCT07724392

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

T piece

Device

The endotracheal tube will be disconnected from the ventilator, and a T-piece (Teleflex, Trach-Vent +®) with oxygen delivery

PSV

Device

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.

HFO

Device

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.

Primary outcomes

  1. 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.

    Time frame: 190 min

Secondary outcomes

  1. Tidal Volume

    Time frame: 190 min

  2. Total Positive End-Expiratory Pressure

    Time frame: 190 min

  3. Respiratory Rate

    Time frame: 190 min

  4. minute ventilation

    Time frame: 190 min

  5. Ratio Respiratory rate/ Tidal volume

    Time frame: 190 min

  6. product pressure time

    Time frame: 190 min

  7. Occlusion pressure (or P 0.1)

    Time frame: 190 min

  8. Percentage of success on the weaning test (predefined criteria)

    Time frame: 190 min

Other outcomes

  1. Percentage of patients extubated following the series of weaning trials

    Time frame: 190 min

  2. Percentage of reintubations within 48 hours after extubation

    Time frame: 52 hours

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: OTRAVAIL

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Jul 24, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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