Bedside Spirometry to see if tidal volume matches ideal body weight in non-intubated ARDS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study uses a handheld spirometer to compare tidal volumes during high-flow oxygen therapy and during non-invasive ventilation with optimized settings in adults with severe hypoxemic ARDS. The aim is to see if a relationship between tidal volumes across these two respiratory supports helps define ARDS phenotypes without intubation. It is designed as an early-phase, exploratory assessment in ICU patients within 24 hours of admission. Interventions include a handheld spirometer and non-invasive ventilation; enrollment requires informed consent and eligibility per predefined respiratory and stability criteria. The study is conducted at CH Vendée and Nantes in France under a Centre Hospitalier sponsor, with no listed collaborators.

Why it matters

Who can join: the full rules

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;

Where it's running

• CHD Vendée
  La Roche-sur-Yon, France Recruiting
• Centre Hospitalier Universitaire de Nantes - Hôpital Hôtel Dieu
  Nantes, France Not yet recruiting

Study contacts

• Principal investigator: Gwenhaël COLIN, Dr — Centre Hospitalier Départemental Vendée
• Study coordinator: Laura SOULARD
• Email: laura.soulard@chd-vendee.fr
• Phone: 02.51.08.05.82

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.