Bedside Spirometry for Acute Lung Injury

NCT07750717 — Not applicable, Recruiting, 30 participants, Centre Hospitalier Departemental Vendee

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Correlation Between Tidal Volume in Spontaneous Ventilation and Tidal Volume in Non-invasive Ventilation in Acute Hypoxemic Non-hypercapnic Respiratory Failure

Registry	NCT07750717, acronym SPIRALI
Status	Recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, basic science
Enrollment	30 (Estimated)
Sponsor	Centre Hospitalier Departemental Vendee (Other)
Conditions	Respiratory Insufficiency
Interventions	Hand-held spirometer, NIV (Device)
Dates	start 2026-10-16, primary completion 2026-10-16, completion 2029-04-16 (estimated), first posted 2026-08-06, last updated 2026-10-19
Locations	2 sites in France

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
tidal volume in spontaneous ventilation and NIV	Experimental	Device: Hand-held spirometer; Device: NIV

Hand-held spirometer (Device): spontaneous ventilation using a hand-held spirometer
NIV (Device): NIV with predefined settings and then with optimized settings

+Outcome measures

Primary outcomes

Show a correlation between the tidal volume measurement in spontaneous ventilation and the tidal volume measurement in NIV [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

+Eligibility

Sex: All, ages: 18 Years to any

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 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;

+Locations (2)

Facility	City	Country	Status
CHD Vendée	La Roche-sur-Yon	France	Recruiting
Centre Hospitalier Universitaire de Nantes - Hôpital Hôtel Dieu	Nantes	France	Not yet recruiting

+Investigators

Gwenhaël COLIN, Dr, Principal investigator, Centre Hospitalier Départemental Vendée