An interventional study of Hand-held spirometer and NIV in Respiratory Insufficiency, sponsored by Centre Hospitalier Departemental Vendee. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Centre Hospitalier Departemental Vendee · Not applicable, Interventional, and Basic science
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.
1,369 studies on the registry are indexed under Respiratory Insufficiency; 264 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 860 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Centre Hospitalier Departemental Vendee is the lead sponsor of 83 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Hand-held spirometer · Device: NIV
spontaneous ventilation using a hand-held spirometer
NIV with predefined settings and then with optimized settings
Show a correlation between the tidal volume measurement in spontaneous ventilation and the tidal volume measurement in NIV
Tidal volume measured by a hand-held spirometer in spontaneous ventilation and exhaled tidal volume measured by the ventilator in NIV after optimization of the settings
Time frame: At T2 and T3, with measurement of VT using a portable spirometer and NIV on the day of enrollment. T1,T2,T3<1h30min
Ran from Oct 2026 to primary completion in Oct 2026, 0 months.
Of 359 non-industry interventional studies with no phase under Respiratory Insufficiency, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's 0 months is below that.
Counting every sponsor, half of 375 studies reached it within 24 months; a quarter within 10 and three quarters within 46.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 19, 2026: start Sep 2026 → Oct 2026, primary completion Sep 2026 → Oct 2026 and completion Jan 2029 → Apr 2029.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centre Hospitalier Departemental Vendee