Hand-held spirometer: spontaneous ventilation using a hand-held spirometer
NIV: NIV with predefined settings and then with optimized settings
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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;
Primary outcome measure(s)
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
Trial sites (1)
Facility
City
Region
Status
Centre Hospitalier Universitaire de Nantes - Hôpital Hôtel Dieu
Nantes
France
More Centre Hospitalier Departemental Vendee trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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