Bedside Spirometry for Acute Lung Injury

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

• 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]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Basic science

Study locations

France · 1 center

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

Identifiers

NCT: NCT07750717 · CHD193-19

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗