Spontaneous Breathing Trial in ICUOTRAVAILNCT07724392
Effect of High-Flow Humidified Oxygen on Ventilatory Work During the Spontaneous Breathing Trial
A study testing T piece, PSV and HFO in people with Spontaneous Breathing Trial in ICU, run by University Hospital, Grenoble.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spontaneous Breathing Trial in ICU
- What is being tested?
- T piece, PSV and HFO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- 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
About this study
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).
- Conditions
- Spontaneous Breathing Trial in ICU
- Being tested
- T piece, PSV, HFO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T pieceDevice
The endotracheal tube will be disconnected from the ventilator, and a T-piece (Teleflex, Trach-Vent +®) with oxygen delivery
PSVDevice
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.
HFODevice
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.
| Study group | Role | What they receive |
|---|---|---|
| TP/HFO/PSV | Other | T piece follow by HFO follow by PSV Receives: Device: T piece; Device: PSV; Device: HFO |
| TP/PSV/HFO | Other | T piece follow by PSV follow by HFO Receives: Device: T piece; Device: PSV; Device: HFO |
| PSV/HFO/TP | Other | PSV follow by HFO follow by T piece Receives: Device: T piece; Device: PSV; Device: HFO |
| PSV/TP/HFO | Other | PSV follow by T piece follow by HFO Receives: Device: T piece; Device: PSV; Device: HFO |
| HFO/TP/PSV | Other | HFO follow by T piece follow by PSV Receives: Device: T piece; Device: PSV; Device: HFO |
| HFO/PSV/TP | Other | HFO follow by PSV follow by TP Receives: Device: T piece; Device: PSV; Device: HFO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 190 min
Secondary outcomes (8)
Tidal Volume
Measured: 190 min
Total Positive End-Expiratory Pressure
Measured: 190 min
Respiratory Rate
Measured: 190 min
minute ventilation
Measured: 190 min
Ratio Respiratory rate/ Tidal volume
Measured: 190 min
product pressure time
Measured: 190 min
Occlusion pressure (or P 0.1)
Measured: 190 min
Percentage of success on the weaning test (predefined criteria)
Measured: 190 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Breathing Trial in ICUStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724392
- Sponsor's protocol ID
- 38RC25.0307
- Acronym
- OTRAVAIL
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-Flow Humidified Oxygen on Ventilatory Work During the Spontaneous Breathing Trial
- ClinicalTrials.gov ID
- NCT07724392
- Acronym / sponsor ID
- OTRAVAIL / 38RC25.0307
- Conditions
- Spontaneous Breathing Trial in ICU
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| TP/HFO/PSV | Other | Device: T piece, Device: PSV, Device: HFOT piece follow by HFO follow by PSV |
| TP/PSV/HFO | Other | Device: T piece, Device: PSV, Device: HFOT piece follow by PSV follow by HFO |
| PSV/HFO/TP | Other | Device: T piece, Device: PSV, Device: HFOPSV follow by HFO follow by T piece |
| PSV/TP/HFO | Other | Device: T piece, Device: PSV, Device: HFOPSV follow by T piece follow by HFO |
| HFO/TP/PSV | Other | Device: T piece, Device: PSV, Device: HFOHFO follow by T piece follow by PSV |
| HFO/PSV/TP | Other | Device: T piece, Device: PSV, Device: HFOHFO follow by PSV follow by TP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
- Capable of undergoing a mechanical ventilation weaning test ("weaning criterion"):
- Patient has an invasive arterial pressure catheter for arterial blood sampling
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T pieceThe endotracheal tube will be disconnected from the ventilator, and a T-piece (Teleflex, Trach-Vent +®) with oxygen delivery | Device | HFO/PSV/TP, HFO/TP/PSV, PSV/HFO/TP, PSV/TP/HFO, TP/HFO/PSV, TP/PSV/HFO |
| PSVThe 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. | Device | HFO/PSV/TP, HFO/TP/PSV, PSV/HFO/TP, PSV/TP/HFO, TP/HFO/PSV, TP/PSV/HFO |
| HFOThe 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. | Device | HFO/PSV/TP, HFO/TP/PSV, PSV/HFO/TP, PSV/TP/HFO, TP/HFO/PSV, TP/PSV/HFO |
Primary outcome
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
8 secondary outcomes
Tidal Volume
Time frame: 190 min
Total Positive End-Expiratory Pressure
Time frame: 190 min
Respiratory Rate
Time frame: 190 min
minute ventilation
Time frame: 190 min
Ratio Respiratory rate/ Tidal volume
Time frame: 190 min
product pressure time
Time frame: 190 min
Occlusion pressure (or P 0.1)
Time frame: 190 min
Percentage of success on the weaning test (predefined criteria)
Time frame: 190 min
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing T piece, PSV and HFO in people with Spontaneous Breathing Trial in ICU, run by University Hospital, Grenoble.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.