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Completed

NCT Number: NCT04119505

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

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

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Key information

Conditions

Dyspnea Acute Respiratory Failure Disease Attributes Emergencies Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of patients with adverse events

    Time frame: 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 outcomes

  1. Delay to initiation of ventilatory support

    Time frame: at day 28

    Ventilatory support is defined as invasive mechanical ventilation or non invasive ventilation or high-flow nasal cannula

  2. Number of patients with adverse events at ED discharge

    Time frame: 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).

  3. Number of patients with adverse events at hospital discharge

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Nord-Vienne Hospital
  • Poitiers University Hospital
  • University Hospital, Brest

Registry information

Official study title

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

Acronym: PREDIRE

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 8, 2019
Registry last updated
Dec 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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