Clinical trial NCT04119505: Value of Diaphragmatic Motion Measurement at Ultrasonography to Predict Poor Prognosis in Emergency Department Patients With Acute Respiratory Failure
Official title: Pronostic Value of Diaphragmatic Excursion Measurement in Patients With Acute Respiratory Failure in the ED.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyspnea
Acute Respiratory Failure
Keywords: Diaphragmatic Excursion
Diaphragmatic Dysfunction
Emergency Department
Respiratory insufficiency
Acute respiratory failure
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Poitiers University Hospital
name: University Hospital, Brest
name: Nord-Vienne Hospital
First posted: 2019-10-08
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients admitted in the Emergency Department for Acute Respiratory Failure

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: 28 days
Secondary outcomes:
measure: Delay to initiation of ventilatory support
timeFrame: at day 28
measure: Number of patients with adverse events at ED discharge
timeFrame: through ED stay (up to a day)
measure: Number of patients with adverse events at hospital discharge
timeFrame: through hospital stay (up to a week)
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Nicolas MARJANOVIC, MD
role: PRINCIPAL_INVESTIGATOR
References: