Value of Diaphragmatic Motion Measurement at Ultrasonography to Predict Poor Prognosis in Emergency Department Patients With Acute Respiratory Failure

Dyspnea Clinical Trial

— PREDIRE  

Official title:

Pronostic Value of Diaphragmatic Excursion Measurement in Patients With Acute Respiratory Failure in the ED.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04119505
• Other study ID #: RECHMPL19_0141
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Dyspnea
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

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)