Acute DyspneaDREAMNCT07132268
Diaphragm Response in Elderly for Acute Monitoring
An observational study of Acute Dyspnea and Acute Respiratory Failure, run by Centre Hospitalier de Bethune at 9 sites in France.
Trial summary
Acute dyspnea is a common cause of emergency department admissions among elderly patients. Acute respiratory failure is often multifactorial and requires rapid and reliable evaluation. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Acute Dyspnea, Acute Respiratory Failure, Diaphragmatic Ultrasound
- How many people
- 145 participants
- Where
- 9 sitesFrance
- Study dates
- Oct 2026to Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients Aged 75 and Over Admitted to the Emergency Department for Acute Dyspnea
Who may be able to join
- Patients aged ≥ 75 years
- Emergency admission for acute dyspnea
- Requiring an emergency ultrsoung.
- Needing to have blood gas levels checked
- no inclusion Criteria:
- Acute respiratory distress requiring immediate invasive or non-invasive ventilation
Show all 18Show fewer
- Respiratory rate ≥ 25 breaths/min, and/or SpO2 ≤ 90%, and/or PaO2 ≤ 60 mmHg, measured at admission on room air or receiving oxygen therapy at ≤ 3L/min.
- Known diaphragmatic paralysis
- Patients with degenerative neuromuscular disease
- State of shock: systolic blood pressure < 90 mmHg and/or mean arterial pressure < 65 mmHg and/or presence of skin mottling and/or CTR > 3s
- Oxygen requirement ≥ 4 L/min
- Arterial lactate levels > 2 mmol/L
- Hypercapnic respiratory acidosis (pH < 7.38 and PaCO2 > 45 mmHg)
- Dyspnea due to metabolic acidosis (e.g., diabetic ketoacidosis, renal failure)
- Dyspnea of traumatic origin
- Refusal to participate or inability to provide informed consent
- Patients deprived of liberty
- Patients under guardianship or curatorship
Who cannot join
None listed.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites
Centre Hospitalier Victor Dupouy
Argenteuil, 95100
Catherine LE GALL, MD
Centre Hospitalier de Béthune
Béthune, 62408
Mélanie VERLAY, 0602013068, mverlay@ch-lens.fr
adubart@ch-bethune.fr
Centre Hospitalier de Douai
Douai, 59507
Olivier HEMAR, MD
Centre Hospitalier Emile Roux
Le Puy-en-Velay, 43000
KWAKYE AGYEMANG Angelo Giordano, MD
Centre Hospitalier Sud Ile-de-France
Melun, 77000
Morsi ELLOUZ, MD
Centre Hospitalier de Roubaix
Roubaix, 59100
Perrine LIBERT, MD
Centre Hospitalier de Saint-Lô
Saint-Lô, 50000
Félix AMIOT, MD
Centre Hospitalier de Tourcoing
Tourcoing, 59208
Florent HENIN, MD
Centre Hospitalier de Valenciennes
Valenciennes, 59300
Alexandre ANDRIES, MD
About this study
Official title: Using Diaphragmatic Ultrasound to Predict Acute Respiratory Distress (ARD) in Patients Aged 75 and Over Admitted to the Emergency Department for Acute Dyspnea : Prospective Multicenter Study.
Acute dyspnea is a common cause of emergency department admissions among elderly patients. Acute respiratory failure is often multifactorial and requires rapid and reliable evaluation. Currently, management relies on clinical, biological, and radiological assessments, but diaphragmatic ultrasound could provide an additional tool for real-time respiratory function evaluation. This study aims to integrate this non-invasive technology into the initial assessment of patients to improve care pathways. Hypothesis : Diaphragmatic ultrasound enables reliable assessment of respiratory function and can predict the need for mechanical ventilation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of a severe acute respiratory event within 7 days of admission
- Placement on invasive mechanical ventilation (intubation) or non invasive ventilation (NIV, high-flow oxygen therapy),
- Respiratory death, confirmed by an independent adjudication committee blinded to the ultrasound results.
Explanatory variable: The presence of impaired diaphragmatic function at admission will be defined by:
- a Tdi (tele-inspiratory thickness) <10%, and/or
- a diaphragmatic excursion <10 mm.
Measured: WITHIN 7 DAYS OF ADMISSION
Secondary outcomes (2)
Measurement of diaphragmatic excursion AND Etiology of acute dyspnea
To study the association between diaphragmatic excursion curve parameters (EDR, inspiratory time, expiratory time, etc.) and the etiology of acute dyspnea in patients aged 75 years and older admitted for acute dyspnea
Measured: within 7 days
To evaluate the contribution of diaphragmatic ultrasound to the NEWS2 score performed on admission in predicting the occurrence of acute respiratory distress within 7 days.
The discriminatory power of the NEWS2 score in predicting the occurrence of acute respiratory distress, the discriminatory power of the NEWS2 score combined with impaired diaphragmatic function on admission ultrasound.
NEWS 2 : The higher the score, the greater the risk of clinical deterioration. 0-4 : low risk Score of 3 in any individual parameter : low-medium 5-6 : moderate risk
> or = 7 : high risk
Measured: within 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study startOct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute DyspneaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Bethune
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Alain-Eric DUBART, Principal investigator, Centre Hospitalier de Béthune-Beuvry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132268
- Sponsor's protocol ID
- 2025-01
- Other IDs
- ID-RCB
- Acronym
- DREAM
- Status last verified
- Oct 2026
- First submitted
- 3 Jul 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Diaphragmatic Ultrasound to Predict Acute Respiratory Distress (ARD) in Patients Aged 75 and Over Admitted to the Emergency Department for Acute Dyspnea : Prospective Multicenter Study.
- ClinicalTrials.gov ID
- NCT07132268
- Acronym / sponsor ID
- DREAM / 2025-01
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Centre Hospitalier de BethuneResearch network
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 20 Aug 2025 (actual)
- 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.
Acute dyspnea is a common cause of emergency department admissions among elderly patients. Acute respiratory failure is often multifactorial and requires rapid and reliable evaluation. Currently, management relies on clinical, biological, and radiological assessments, but diaphragmatic ultrasound could provide an additional tool for real-time respiratory function evaluation. This study aims to integrate this non-invasive technology into the initial assessment of patients to improve care pathways. Hypothesis : Diaphragmatic ultrasound enables reliable assessment of respiratory function and can predict the need for mechanical ventilation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients Aged 75 and Over Admitted to the Emergency Department for Acute Dyspnea
Key inclusion criteria (18 listed)
- Patients aged ≥ 75 years
- Emergency admission for acute dyspnea
- Requiring an emergency ultrsoung.
- Needing to have blood gas levels checked
- Acute respiratory distress requiring immediate invasive or non-invasive ventilation
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of a severe acute respiratory event within 7 days of admission
Time frame: WITHIN 7 DAYS OF ADMISSION
* Placement on invasive mechanical ventilation (intubation) or non invasive ventilation (NIV, high-flow oxygen therapy), * Respiratory death, confirmed by an independent adjudication committee blinded to the ultrasound results. Explanatory variable: The presence of impaired diaphragmatic function at admission will be defined by: * a Tdi (tele-inspiratory thickness) <10%, and/or * a diaphragmatic excursion <10 mm.
2 secondary outcomes
Measurement of diaphragmatic excursion AND Etiology of acute dyspnea
Time frame: within 7 days
To evaluate the contribution of diaphragmatic ultrasound to the NEWS2 score performed on admission in predicting the occurrence of acute respiratory distress within 7 days.
Time frame: within 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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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.
Alain-Eric DUBART principal investigator
Centre Hospitalier de Béthune-Beuvry
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Dyspnea and Acute Respiratory Failure, run by Centre Hospitalier de Bethune at 9 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 18 inclusion and 0 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: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alain-Eric DUBART, Doctor (03.21.64.42.81, adubart@ch-bethune.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of a severe acute respiratory event within 7 days of admission (time frame: WITHIN 7 DAYS OF ADMISSION). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2026.