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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with de novo acute respiratory failure | 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):
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|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diaphragmatic ultrasound and electrical impedance tomography | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Oro-tracheal intubation | Patients who will be intubated within the 7 days after admission in the ICU | 7 days after admission in the ICU |
| Measure | Description | Time Frame |
|---|---|---|
| Diaphragmatic function | using ultrasonography, measure of diaphragmatic excursion and diaphragmatic thickening in Hertz (Hz) | 2 days after inclusion |
| Diaphragmatic function | Diaphragmatic function evaluation by phrenic nerve stimulation (only for intubated patients). |
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Inclusion Criteria:
Age > 18
Acute respiratory insufficiency defined by the three following items :
Non opposition by the patient to be included
Social insurance
Exclusion Criteria:
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Patients with de novo acute respiratory failure
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| Name | Affiliation | Role |
|---|---|---|
| Martin DRES, MD PhD | Assistance Publique - Hôpitaux de Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe Hospitalier Pitié-Salpêtrière", Intensive care unit | Paris | 75013 | France |
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.
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Researchers who provide a methodologically sound proposal.
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| ID | Term |
|---|---|
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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|
| 2 days after inclusion |
| lung regional ventilation | As measured with Electric Impedance Tomography index measures (inhomogeneity index, end expiratory lung impedance change) | 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". | 28 days after inclusion |
| Dyspnea evaluation | Dyspnea evaluation using Respiratory Distress Observation Scale (RDOS) | 28 days after inclusion |
| Mechanical ventilation duration | (only for intubated patients). | 28 days after inclusion |
| ICU length of stay | for all patients | 28 days after inclusion |
| ICU mortality | for all patients | 28 days after inclusion |
| D013568 | Pathological Conditions, Signs and Symptoms |