The diagnosis of Acute Respiratory Distress Syndrome (ARDS) is a syndromic diagnosis that groups together patients who may have very different prognoses and respond differently to the same therapies.
Additionally, non-invasive ventilation (NIV) has shown highly contrasting results in the early management of ARDS. One of the predictive criteria for NIV failure is an excessively high tidal volume during non-invasive ventilation.
SPIRALI is a pilot study evaluating the relevance of a respiratory physiology parameter, the tidal volume relative to the theoretical ideal body weigh, in the phenotypic classification of non-intubated ARDS patients. In this initial approach, the investigators will compare the tidal volume during high-flow oxygen therapy with the tidal volume obtained under NIV (after applying a settings optimization algorithm). The investigators hypothesize that if tidal volume is linked to each situation, the same patients will exhibit a high tidal volume both during spontaneous ventilation and under NIV.
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:
* Patient over 18 years of age;
* Patient hospitalized in intensive care for less than 24 hours;
* Patient with severe hypoxemic acute respiratory failure characterized by a PaO2/FiO2 ratio \< 300 mmHg and \> 150 mmHg under high-flow oxygen therapy at 60 L/min;
* Patient able to cooperate with the spirometry test;
* Patient able to follow the protocol and having given their informed written consent to participate in the study;
* Patient affiliated with the social security system or entitled to benefits;
Exclusion Criteria:
* Patients with an indication for intubation;
* Patients with a contraindication for or who refuse NIV;
* Patients with hemodynamic instability requiring vasopressor support greater than 0.25 μg/kg/min of norepinephrine;
* Patients with a Glasgow score \< 15;
* Patients with hypercapnia (PaCO2 \> 45 mmHg);
* Patients with a PaO2/FiO2 ratio \< 150 mmHg;
* Patients with cardiogenic pulmonary edema;
* Patients who have already undergone a session of NIV in intensive care during this stay;
* Patients with chronic respiratory failure (home oxygen therapy or home non-invasive ventilation (excluding indications solely for sleep apnea syndrome));
* Patients who have recently had a pneumothorax;
* Patients who have recently undergone eye surgery (e.g., cataract surgery) or throat surgery;
* Patients with significant arterial disease: recent heart attack, pulmonary embolism, poorly controlled hypertension despite treatment, etc.
* Patients alre…
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
Show a correlation between the tidal volume measurement in spontaneous ventilation and the tidal volume measurement in NIV
Timeframe: At T2 and T3, with measurement of VT using a portable spirometer and NIV on the day of enrollment. T1,T2,T3<1h30min