ClinicalTrials.gg
RecruitingNCT07750717SPIRALIUpdated Oct 19, 2026

Bedside Spirometry for Acute Lung Injury

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

Updated Oct 19, 2026Now RecruitingSite recruiting status changed+4 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Respiratory Insufficiency
03

In context

Respiratory Insufficiency

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

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

Exclusion Criteria:

  • Patients with an indication for intubation;
  • Patients with a 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 already included in the study;
  • Pregnant women, women in labor, or women who are breastfeeding;
  • Patients under guardianship, conservatorship, or deprived of their liberty;
  • Patients under an activated future protection mandate;
  • Patients under family authorization;
  • Patients under judicial protection;
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    tidal volume in spontaneous ventilation and NIV

    Device: Hand-held spirometer · Device: NIV

Interventions

  • DeviceHand-held spirometer

    spontaneous ventilation using a hand-held spirometer

  • DeviceNIV

    NIV with predefined settings and then with optimized settings

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 of 2 sites recruiting
  • CHD Vendée
    La Roche-sur-Yon, France
    Recruiting
  • Centre Hospitalier Universitaire de Nantes - Hôpital Hôtel Dieu
    Nantes, 44093, France
    Not yet recruiting
    • Jean Baptiste LASCARROU, Dr · Principal investigator
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

Registered
May 19, 2026
First posted
Aug 6, 2026
StartActual
Oct 16, 2026was Sep 2026
Primary completionActual
Oct 16, 2026was Sep 2026
CompletionEst.
Apr 16, 2029was Jan 2029
Last update
Oct 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 19, 2026
Sites
1 site added. Centre Hospitalier Universitaire de Nantes - Hôpital Hôtel Dieu is now Not yet recruiting
Show site
  • CHD Vendée · La Roche-sur-Yon, France
Oct 19, 2026
Start date
Sep 30, 2026→Oct 16, 2026 (actual)
Oct 19, 2026
Primary completion
Sep 30, 2026→Oct 16, 2026 (actual)
Oct 19, 2026
Study completion
Jan 1, 2029→Apr 16, 2029
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    Not yet recruiting→Recruiting
    1 site added. Centre Hospitalier Universitaire de Nantes - Hôpital Hôtel Dieu is now Not yet recruiting
    Show site
    • CHD Vendée · La Roche-sur-Yon, France
    Start date Sep 30, 2026→Oct 16, 2026 (now actual)
    Primary completion Sep 30, 2026→Oct 16, 2026 (now actual)
    Study completion Jan 1, 2029→Apr 16, 2029
    + 1 other change: verification date

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 ↗

09

Registry details

Key details

Study ID
NCT07750717
Lead sponsor
Centre Hospitalier Departemental Vendee
Responsible party
Sponsor
First posted
Aug 6, 2026
Start date
Oct 16, 2026
Primary completion
Oct 16, 2026
Completion
Apr 16, 2029 (estimated)
Last update
Oct 19, 2026

Study contacts

Laura SOULARD
Contact
laura.soulard@chd-vendee.fr
02.51.08.05.82 ext. +33
Gwenhaël COLIN, Dr
principal investigator · Centre Hospitalier Départemental Vendée

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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