Effect of High-Flow Humidified Oxygen on Ventilatory Work During the Spontaneous Breathing Trial (NCT07724392) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of High-Flow Humidified Oxygen on Ventilatory Work During the Spontaneous Breathing Trial
30 participantsStarted 2027-01
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.