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

NCT04119505 | Completed

• 1 other identifier: RECHMPL19_0141
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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

Conditions

Dyspnea; Acute Respiratory Failure

Keywords

Diaphragmatic Excursion; Diaphragmatic Dysfunction; Emergency Department; Respiratory insufficiency; Acute respiratory failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Delay to initiation of ventilatory support

  at day 28

• Number of patients with adverse events at ED discharge

  through ED stay (up to a day)

• Number of patients with adverse events at hospital discharge

  through hospital stay (up to a week)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted in the Emergency Department for Acute Respiratory Failure

You may qualify if:

• 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

You may not qualify if:

• Medical history of diaphragmatic dysfunction including stroke or diaphragmatic paralysis
• Patients treated with curare
• Trauma patients

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Poitiers University Hospital: collaborator
• University Hospital, Brest: collaborator
• Nord-Vienne Hospital: collaborator

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Dyspnea; Emergencies; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Nicolas MARJANOVIC, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: October 8, 2019
• Study Start: November 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: December 28, 2020
• Last Updated: December 29, 2020

Record last verified: 2020-12

Locations

FR (1)