Bedside Spirometry for Acute Lung Injury

Starting soon · Not applicable

Conditions studied: Respiratory Insufficiency

In brief

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.

Key facts

Study ID

NCT07750717

Run by

Centre Hospitalier Departemental Vendee

People needed

30

Starts

2026-09-30

Expected to finish

2029-01-01

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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;

Where it is running

• Centre Hospitalier Universitaire de Nantes - Hôpital Hôtel Dieu — Nantes, France

Full record on ClinicalTrials.gov

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