NCT02273687

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2014

Completed
5 days until next milestone

Study Start

First participant enrolled

October 29, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

November 19, 2025

Status Verified

January 1, 2018

Enrollment Period

2.9 years

First QC Date

October 22, 2014

Last Update Submit

November 17, 2025

Conditions

Respiratory Distress Syndrome, Adult

Keywords

diaphragm movementultrasoundemergency room

Outcome Measures

Primary Outcomes (2)

  • Measurement of diaphragmatic excursion by M-mode ultrasound

    in centimeters

    Day 0, baseline

  • Use of ventilation within the first 4 hours

    yes/no

    Day 0, baseline + 4 hours

Secondary Outcomes (4)

  • Measurement of diaphragmatic excursion by M-mode ultrasound

    Day 0, baseline + 4 hours

  • Acute respiratory distress signs within the first 4 hours

    Day 0, baseline + 4 hours

  • Signs of respiratory re aggravation at 24 hours

    Day 1

  • Diagnosis

    Day 1

Study Arms (1)

Prognostic study population

EXPERIMENTAL

The study population consists of patients treated for acute respiratory distress in the emergency department at the Nîmes University Hospital. See inclusion and exclusion criteria. Intervention: Diaphragmatic ultrasound

Device: Vivid S6 GE Ultrasound

Interventions

Vivid S6 GE UltrasoundDEVICE

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.

Prognostic study population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

CH de Perpignan - Hôpital Saint Jean

Perpignan, 66046, France

Location

Related Publications (1)

  • Clement A, Zieleskiewicz L, Bonnec JM, Occean BV, Bastide S, Muller L, de La Coussaye JE, Boussuges A, Claret PG, Bobbia X. Diaphragmatic excursion measurement in emergency department patients with acute dyspnea to predict mechanical ventilation use. Am J Emerg Med. 2020 Oct;38(10):2081-2087. doi: 10.1016/j.ajem.2020.06.044. Epub 2020 Jun 26.

    PMID: 33142179RESULT

MeSH Terms

Conditions

Respiratory Distress SyndromeEmergencies

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Xavier Bobbia, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2014

First Posted

October 24, 2014

Study Start

October 29, 2014

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

November 19, 2025

Record last verified: 2018-01

Locations

FR(2)