An observational study in Acute Respiratory Failure, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
Modern management of acute respiratory failure aims to relieve dyspnea and anxiety by providing a non-invasive respiratory support. This approach tries to avoid endotracheal intubation, patient self inflicted lung injuries (PSILI) and diaphragmatic dysfunction. The present study aims to evaluate dyspnea, pulmonary regional ventilation and diaphragmatic function in patients with hypoxemic acute respiratory failure by different observations, and to bring risk factor for intubation out.
Patients aged of 18 years or more, presenting with an acute respiratory failure without hypercapnia will be included in the study. Clinical and biological variables, dyspnea assessment, regional lung ventilation (electrical impedance tomography) and diaphragm function (ultrasound) will be evaluated at inclusion and at 2 hours, 4 hours and 48 hours after inclusion. In case of intubation, diaphragmatic function will be also evaluated with phrenic nerve stimulation technique.
Primary endpoint is intubation at day 7. Secondary endpoints are measurement of dyspnea, pulmonary ventilation and diaphragmatic function, also ventilator free days, ICU length of stay and mortality.
656 studies on the registry are indexed under Dyspnea; 153 are open to participants now.
This study's enrollment of 55 is below the median of 122 across 204 observational studies indexed under Dyspnea.
Browse Dyspnea studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,506 studies on the registry; 1,007 are open to participants now.
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Patients with de novo acute respiratory failure
Acute respiratory insufficiency defined by the three following items :
Exclusion Criteria:
The following tests will be performed as part of the research (these tests are usually performed as part of routine care but not routinely and comprehensively): * A diaphragmatic ultrasound in the half-seated position. Diaphragmatic excursion and thickening fraction will be measured in the right hemi-diaphragm. * A 10-minute reference acquisition. They will be performed at inclusion, H2, H4 and H48.
Other: Diaphragmatic ultrasound and electrical impedance tomography
A diaphragmatic ultrasound in a half sitting position. The diaphragmatic excursion and the thickening fraction of the right hemi-diaphragm will be measured. \- Acquisition of 10 minutes of regional pulmonary ventilation by electrical impedance tomography.
Oro-tracheal intubation
Patients who will be intubated within the 7 days after admission in the ICU
Time frame: 7 days after admission in the ICU
Diaphragmatic function
using ultrasonography, measure of diaphragmatic excursion and diaphragmatic thickening in Hertz (Hz)
Time frame: 2 days after inclusion
Diaphragmatic function
Diaphragmatic function evaluation by phrenic nerve stimulation (only for intubated patients).
Time frame: 2 days after inclusion
lung regional ventilation
As measured with Electric Impedance Tomography index measures (inhomogeneity index, end expiratory lung impedance change)
Time frame: 2 days after inclusion
Dyspnea evaluation
Dyspnea evaluation using visual analogue scale applied to dyspnea: from 1 to 10, 1 corresponding to "no breathlessness" and 10 to "maximum breathlessness".
Time frame: 28 days after inclusion
Dyspnea evaluation
Dyspnea evaluation using Respiratory Distress Observation Scale (RDOS)
Time frame: 28 days after inclusion
Mechanical ventilation duration
(only for intubated patients).
Time frame: 28 days after inclusion
ICU length of stay
for all patients
Time frame: 28 days after inclusion
ICU mortality
for all patients
Time frame: 28 days after inclusion
Plan to share: Yes — The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Supporting information: Study protocol, Icf
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris