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

Completed

• Conditions: Dyspnea; Acute Respiratory Failure

• Registration Number: NCT04119505
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study First Submitted: 2019-09-25
• Study First Submitted QC: 2019-10-07
• Study First Posted: 2019-10-08
• Study Start: 2019-11-01
• Primary Completion: 2020-11-01
• Status Verified: 2020-12
• Study Completion: 2020-12-28
• Last Update Submitted: 2020-12-28
• Last Update Posted: 2020-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse events	28 days	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.

Secondary Outcome Measures

Name	Time	Method
Number of patients with adverse events at ED discharge	through ED stay (up to a day)	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).
Delay to initiation of ventilatory support	at day 28	Ventilatory support is defined as invasive mechanical ventilation or non invasive ventilation or high-flow nasal cannula
Number of patients with adverse events at hospital discharge	through hospital stay (up to a week)	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).

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France