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Completed

NCT Number: NCT02273687

Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in Emergency Department

The main objective of this study is to show that "diaphragmatic excursion measures upon emergency admission" (CDA values) on patients with acute respiratory failure are predictive of the need to use mechanical ventilation (invasive or non-) in the first four hours.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Nîmes - Hôpital Universitaire Carémeau, Nîmes, France

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About this study

The secondary objectives of this study are:

A-determine a prognostic threshold for diaphragmatic excursion measures able to predict the use of mechanical ventilation (invasive or not) in the first four hours.

B-to study the association between CDA values and persistence of respiratory distress during the first 4 hours of care among patients who, at 4 hours, are not mechanically ventilated.

C-to study the association between CDA values and respiratory re-exacerbation or a continuing need for mechanical ventilation during the 24 first hours after admission to the emergency room D-to study the association between diaphragmatic excursion measures made after initial emergency care (at 4 hours; =CDH4), and the persistence of respiratory distress at 4 hours, in patients who at 4 hours are not mechanically ventilated.

E-to study the association between CDH4 values and respiratory re-exacerbation during the 24 first hours after admission to the emergency room among patients who, at 4 hours, are not mechanically ventilated F-to study the association between changes in values of diaphragmatic excursion measure before and after initial emergency care (CDA → CDH4) and respiratory re-exacerbation during the 24 first hours after admission to the emergency room among patients who, at 4 hours, are not mechanically ventilated.

G-analyze patient outcomes by subgroup according to diagnosis (decompensated COPD, OAP, lung disease, asthma, pleural disease).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The patient has given informed consent (and signed the consent form) or, in case of an emergency situation, an investigator has committed to obtaining the consent of the patient as soon as his/her condition permits
  • Patient affiliated with or beneficiary of a health insurance plan
  • Acute Respiratory Distress (DRA) defined by: (1) respiratory rate > 25 and/or signs of struggle and hypoxia AND (2) SpO2 values < 90% and/or [pH < 7.35 and pCO2 > 6 kPa (45 mm Hg)]
  • Breathing spontaneously (no ventilation)

Exclusion criteria

  • Patient currently participating in or having participated in another interventional study in the previous three months, or patient in an exclusion period determined by a previous study
  • Patient under judicial protection or any kind of guardianship
  • Refusal to sign the consent
  • Patient pregnant, parturient, or lactating
  • Neurological or neuromuscular disease modifying the operation of the diaphragm without any decompensation (Polyneuropathy, Lou Gehrig's disease, Myasthenia ...)
  • Patient who received mechanical ventilation at home
  • Patient who received treatment by mechanical ventilation during the pre-hospitalization care phase
  • Patient admitted with respiratory failure requiring immediate installation of a mechanical ventilation and thus not allowing the performance of two ultrasound measurements
  • Patient suffering from a pneumothorax

Treatment and study plan

Vivid S6 GE Ultrasound

Device

Diaphragmatic ultrasound will be performed by the physician supporting the patient on arrival and also at 4 hours later in the beginning of therapeutic management. The patient will be monitored for 24 hours following inclusion.

The exams will all be done with the same ultrasound system (Vivid S6 GE Ultrasound) and a phased array probe, also called a cardiac probe.

Primary outcomes

  1. Measurement of diaphragmatic excursion by M-mode ultrasound

    Time frame: Day 0, baseline

    in centimeters

  2. Use of ventilation within the first 4 hours

    Time frame: Day 0, baseline + 4 hours

    yes/no

Secondary outcomes

  1. Measurement of diaphragmatic excursion by M-mode ultrasound

    Time frame: Day 0, baseline + 4 hours

    in centimeters

  2. Acute respiratory distress signs within the first 4 hours

    Time frame: Day 0, baseline + 4 hours

    yes/no

  3. Signs of respiratory re aggravation at 24 hours

    Time frame: Day 1

    yes/no

  4. Diagnosis

    Time frame: Day 1

    qualitative variable: decompensated COPD, OAP, pneumonia, asthma, or pleural pathology

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Analysis of Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in Emergency Department: Predicting Respiratory Prognosis

Acronym: EDDRAPro

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 24, 2014
Registry last updated
Nov 19, 2025

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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