Bedside Spirometry for Acute Lung Injury
ConditionRespiratory Insufficiency
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Departemental Vendee
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Hand-held spirometer
Devicespontaneous ventilation using a hand-held spirometer
NIV
DeviceNIV with predefined settings and then with optimized settings
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: tidal volume in spontaneous ventilation and NIVExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Show a correlation between the tidal volume measurement in spontaneous ventilation and the tidal volume measurement in NIV
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
Time frame
At T2 and T3, with measurement of VT using a portable spirometer and NIV on the day of enrollment. T1,T2,T3<1h30minSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: