Respiratory Distress Syndrome, AdultEDDRAProNCT02273687
Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in Emergency Department
A study testing Vivid S6 GE Ultrasound in people with Respiratory Distress Syndrome, Adult, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome, Adult
- What is being tested?
- Vivid S6 GE Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 2 sitesFrance
- Study dates
- 29 Oct 2014to 30 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
CH de Perpignan - Hôpital Saint Jean
Perpignan, 66046
About this study
Official title: Analysis of Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in Emergency Department: Predicting Respiratory Prognosis
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.
Read the detailed description
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).
- Conditions
- Respiratory Distress Syndrome, Adult
- Being tested
- Vivid S6 GE Ultrasound
- Keywords
- diaphragm movement, ultrasound, emergency room
- Medical subject headings
- Respiratory Distress Syndrome, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Vivid S6 GE Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of diaphragmatic excursion by M-mode ultrasound
in centimeters
Measured: Day 0, baseline
Use of ventilation within the first 4 hours
yes/no
Measured: Day 0, baseline + 4 hours
Secondary outcomes (4)
Measurement of diaphragmatic excursion by M-mode ultrasound
in centimeters
Measured: Day 0, baseline + 4 hours
Acute respiratory distress signs within the first 4 hours
yes/no
Measured: Day 0, baseline + 4 hours
Signs of respiratory re aggravation at 24 hours
yes/no
Measured: Day 1
Diagnosis
qualitative variable: decompensated COPD, OAP, pneumonia, asthma, or pleural pathology
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study start29 Oct 2014
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier Bobbia, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02273687
- Sponsor's protocol ID
- LOCAL/20143/XBAC-01
- Other IDs
- 2014-A00511-46
- Acronym
- EDDRAPro
- Status last verified
- Jan 2018
- First submitted
- 22 Oct 2014
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33142179
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in Emergency Department: Predicting Respiratory Prognosis
- ClinicalTrials.gov ID
- NCT02273687
- Acronym / sponsor ID
- EDDRAPro / LOCAL/20143/XBAC-01
- Conditions
- Respiratory Distress Syndrome, Adult
- Keywords
- diaphragm movement, ultrasound, emergency room
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 29 Oct 2014 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 24 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prognostic study population | Experimental | Device: Vivid S6 GE UltrasoundThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- 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 ...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vivid S6 GE UltrasoundDiaphragmatic 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. | Device | Prognostic study population |
Primary outcome
Measurement of diaphragmatic excursion by M-mode ultrasound
Time frame: Day 0, baseline
in centimeters
Use of ventilation within the first 4 hours
Time frame: Day 0, baseline + 4 hours
yes/no
4 secondary outcomes
Measurement of diaphragmatic excursion by M-mode ultrasound
Time frame: Day 0, baseline + 4 hours
Acute respiratory distress signs within the first 4 hours
Time frame: Day 0, baseline + 4 hours
Signs of respiratory re aggravation at 24 hours
Time frame: Day 1
Diagnosis
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Results publication: PubMed 33142179Clement 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier Bobbia, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vivid S6 GE Ultrasound in people with Respiratory Distress Syndrome, Adult, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of diaphragmatic excursion by M-mode ultrasound (time frame: Day 0, baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02273687, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.