Respiratory InsufficiencySPIRALINCT07750717
Bedside Spirometry for Acute Lung Injury
A study testing Hand-held spirometer and NIV in people with Respiratory Insufficiency, run by Centre Hospitalier Departemental Vendee at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- Hand-held spirometer and NIV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Oct 2026to 16 Apr 2029
- 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
- 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;
Who cannot join
- 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;
Show all 18Show fewer
- 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;
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHD Vendée
La Roche-sur-Yon
Gwenhael COLIN, 02 51 44 65 72, gwenhael.colin@ght85.fr
- Not yet recruiting
Centre Hospitalier Universitaire de Nantes - Hôpital Hôtel Dieu
Nantes, 44093
Jean Baptiste LASCARROU, Dr
About this study
Official title: Correlation Between Tidal Volume in Spontaneous Ventilation and Tidal Volume in Non-invasive Ventilation in Acute Hypoxemic Non-hypercapnic Respiratory Failure
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.
- Conditions
- Respiratory Insufficiency
- Being tested
- Hand-held spirometer, NIV
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand-held spirometerDevice
spontaneous ventilation using a hand-held spirometer
NIVDevice
NIV with predefined settings and then with optimized settings
| Study group | Role | What they receive |
|---|---|---|
| tidal volume in spontaneous ventilation and NIV | Experimental | Not described Receives: Device: Hand-held spirometer; Device: NIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At T2 and T3, with measurement of VT using a portable spirometer and NIV on the day of enrollment. T1,T2,T3<1h30min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start16 Oct 2026
- Primary completion16 Oct 2026
- Study completion16 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gwenhaël COLIN, Dr, Principal investigator, Centre Hospitalier Départemental Vendée
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750717
- Sponsor's protocol ID
- CHD193-19
- Acronym
- SPIRALI
- Status last verified
- Oct 2026
- First submitted
- 19 May 2026
- Last updated
- 19 Oct 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 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Tidal Volume in Spontaneous Ventilation and Tidal Volume in Non-invasive Ventilation in Acute Hypoxemic Non-hypercapnic Respiratory Failure
- ClinicalTrials.gov ID
- NCT07750717
- Acronym / sponsor ID
- SPIRALI / CHD193-19
- Conditions
- Respiratory Insufficiency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 16 Oct 2026 (actual)
- Primary completion
- 16 Oct 2026 (actual)
- Study completion
- 16 Apr 2029 (estimated)
- First posted
- 6 Aug 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tidal volume in spontaneous ventilation and NIV | Experimental | Device: Hand-held spirometer, Device: NIV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (18 listed)
- 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);
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 |
|---|---|---|
| Hand-held spirometerspontaneous ventilation using a hand-held spirometer | Device | tidal volume in spontaneous ventilation and NIV |
| NIVNIV with predefined settings and then with optimized settings | Device | tidal volume in spontaneous ventilation and NIV |
Primary outcome
Show a correlation between the tidal volume measurement in spontaneous ventilation and the tidal volume measurement in NIV
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
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
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 19 Oct 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.
Gwenhaël COLIN, Dr principal investigator
Centre Hospitalier Départemental Vendée
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand-held spirometer and NIV in people with Respiratory Insufficiency, run by Centre Hospitalier Departemental Vendee at 2 sites in France.
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 6 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Laura SOULARD (02.51.08.05.82 ext. +33, laura.soulard@chd-vendee.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Show a correlation between the tidal volume measurement in spontaneous ventilation and the tidal volume measurement in NIV (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). 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 19 Oct 2026.