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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04119505
Other study ID # RECHMPL19_0141
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2019
Est. completion date December 28, 2020

Study information

Verified date December 2020
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Acute respiratory failure is one of the most common diagnosis in patients admitted in the Emergency Department. Acute respiratory failure is associated with morbidity and mortality. Fifteen percent of patient will require ventilatory support and among them 40% will die. Measurement of diaphragmatic motion (excursion) at ultrasonography is a noninvasive measure, allowing to assess diaphragm dysfunction. It could be useful in predicting poor prognosis in ED patients with respiratory failure . In this study the investigators will compare the prognostic value of diaphragmatic excursion measurement at ultrasonography to that of the National Early Warning Score (NEWS) 2 in patients presenting with acute respiratory failure in the ED The Investigators made the hypothesis that measurement of diaphragmatic excursion in ED patients with acute respiratory failure could be of value in predicting the need for ventilatory support or mortality within 28 days from ED admission


Description:

Diaphragmatic dysfunction can be explored by measuring diaphragmatic excursion using ultrasonography in spontaneous ventilation patients. Patients in spontaneous ventilation will undergo both diaphragmatic excursion measurement at ultrasonography and assessment of the News2 score as part of standard care.


Recruitment information / eligibility

Status Completed
Enrollment 350
Est. completion date December 28, 2020
Est. primary completion date November 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - Age equal or over 18 y.o - Signs of acute respiratory failure defined by RR equal or over 25 br/min and/or signs of increased work of breathing - Patients on spontaneous breathing Exclusion criteria: - Medical history of diaphragmatic dysfunction including stroke or diaphragmatic paralysis - Patients on ventilatory support at ED admission or prior to inclusion - Patients treated with curare - Trauma patients

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (4)

Lead Sponsor Collaborator
University Hospital, Montpellier Nord-Vienne Hospital, Poitiers University Hospital, University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with adverse events Adverse events are defined as a composite of mortality and/or cardiac arrest and/or need for ventilatory support (including invasive and/or noninvasive ventilation and/or high flow nasal cannula therapy) within 28 days from ED admission. 28 days
Secondary Delay to initiation of ventilatory support Ventilatory support is defined as invasive mechanical ventilation or non invasive ventilation or high-flow nasal cannula at day 28
Secondary Number of patients with adverse events at ED discharge Adverse events are defined as a composite of mortality and/or cardiac arrest and/or need for ventilatory support (including invasive and/or noninvasive ventilation and/or high flow nasal cannula therapy). through ED stay (up to a day)
Secondary Number of patients with adverse events at hospital discharge Adverse events are defined as a composite of mortality and/or cardiac arrest and/or need for ventilatory support (including invasive and/or noninvasive ventilation and/or high flow nasal cannula therapy). through hospital stay (up to a week)
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