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

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

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

Study Overview

• Status: Completed
• Conditions: Dyspnea; Acute Respiratory Failure

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.

• Study Type: Observational
• Enrollment (Actual): 350

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • UHMontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted in the Emergency Department for Acute Respiratory Failure

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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)

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Poitiers University Hospital; University Hospital, Brest; Nord-Vienne Hospital
• Investigators: Principal Investigator: Nicolas MARJANOVIC, MD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): December 28, 2020

Study Registration Dates

• First Submitted: September 25, 2019
• First Submitted That Met QC Criteria: October 7, 2019
• First Posted (Actual): October 8, 2019

Study Record Updates

• Last Update Posted (Actual): December 29, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Emergency Department; Acute respiratory failure; Respiratory insufficiency; Diaphragmatic Excursion; Diaphragmatic Dysfunction
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Respiratory Distress Syndrome; Dyspnea
• Other Study ID Numbers: RECHMPL19_0141

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No