Effect of High-Flow Humidified Oxygen on Ventilatory Work During the Spontaneous Breathing Trial
OTRAVAIL
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2027
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2026
CompletedFirst Posted
Study publicly available on registry
July 24, 2026
CompletedStudy Start
First participant enrolled
January 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
Study Completion
Last participant's last visit for all outcomes
January 1, 2027
July 24, 2026
July 1, 2026
Same day
July 20, 2026
July 20, 2026
Conditions
Outcome Measures
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.
190 min
Secondary Outcomes (8)
Tidal Volume
190 min
Total Positive End-Expiratory Pressure
190 min
Respiratory Rate
190 min
minute ventilation
190 min
Ratio Respiratory rate/ Tidal volume
190 min
- +3 more secondary outcomes
Other Outcomes (2)
Percentage of patients extubated following the series of weaning trials
190 min
Percentage of reintubations within 48 hours after extubation
52 hours
Study Arms (6)
TP/HFO/PSV
OTHERT piece follow by HFO follow by PSV
TP/PSV/HFO
OTHERT piece follow by PSV follow by HFO
PSV/HFO/TP
OTHERPSV follow by HFO follow by T piece
PSV/TP/HFO
OTHERPSV follow by T piece follow by HFO
HFO/TP/PSV
OTHERHFO follow by T piece follow by PSV
HFO/PSV/TP
OTHERHFO follow by PSV follow by TP
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
- +2 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2026
First Posted
July 24, 2026
Study Start (Estimated)
January 1, 2027
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
July 24, 2026
Record last verified: 2026-07