Respiration, ArtificialEVALDMNCT03447366
Mitral Doppler as a Predictor of Respiratory Worsening After Vascular Filling
A study testing mitral doppler in people with Respiration, Artificial and Vascular Filling, run by Centre Hospitalier Metropole Savoie at 3 sites in France.
Trial summary
Interventional study of the accuracy of a non-invasive testing by echocardiography to predict respiratory worsening after vascular filling. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiration, Artificial, Vascular Filling, Echocardiography
- What is being tested?
- mitral doppler
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 3 sitesFrance
- Study dates
- 30 Jan 2018to 30 Apr 2022
- 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
- Mechanical ventilation
- And hemodynamic failure
- And decision of the attending physician to perform a vascular filling
Who cannot join
- Pregnancy and breast-feeding women
- Patients deprived of their administrative or judicial freedom
Trial locations and contacts
3 sites in 1 country.
France3 sites
Ch Bourg En Bresse
Bourg-en-Bresse
Centre Hospitalier Metropole Savoie
Chambéry, 73000
CHU Grenoble Alpes
La Tronche, 38700
About this study
Official title: Assessment of Mitral Doppler as a Predictor of Respiratory Worsening After Vascular Filling for ICU Patients With Mechanical Ventilation. The EVALDM Study
Interventional study of the accuracy of a non-invasive testing by echocardiography to predict respiratory worsening after vascular filling.
Read the detailed description
Mitral Doppler will be performed before vascular filling. Patients will be classified in two groups (normal or high cardiac filling pressure).
The evolution of the respiratory data (SpO2/FiO2) of the two groups of the patients before and after vascular filling will be compared.
- Conditions
- Respiration, Artificial, Vascular Filling, Echocardiography
- Being tested
- mitral doppler
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mitral dopplerDiagnostic test
Mitral doppler before and after vascular filling
| Study group | Role | What they receive |
|---|---|---|
| Mitral doppler | Experimental | Mitral doppler before and after vascular filling Receives: Diagnostic Test: mitral doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of the occuring of premature degradation respiratory
definied by a reduction of at least 15% of the SpO2/FiO2 ratio in the 30min following the vascular filling
Measured: 30 minutes after vascular filling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start30 Jan 2018
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration, ArtificialStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Metropole Savoie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447366
- Sponsor's protocol ID
- 2017-A02313-50
- Acronym
- EVALDM
- Status last verified
- Jun 2026
- First submitted
- 2 Feb 2018
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Mitral Doppler as a Predictor of Respiratory Worsening After Vascular Filling for ICU Patients With Mechanical Ventilation. The EVALDM Study
- ClinicalTrials.gov ID
- NCT03447366
- Acronym / sponsor ID
- EVALDM / 2017-A02313-50
- Conditions
- Respiration, Artificial, Vascular Filling, Echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Centre Hospitalier Metropole SavoieUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 27 Feb 2018 (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.
Interventional study of the accuracy of a non-invasive testing by echocardiography to predict respiratory worsening after vascular filling.
Detailed description
Mitral Doppler will be performed before vascular filling. Patients will be classified in two groups (normal or high cardiac filling pressure).
The evolution of the respiratory data (SpO2/FiO2) of the two groups of the patients before and after vascular filling will be compared.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mitral doppler | Experimental | Diagnostic Test: mitral dopplerMitral doppler before and after vascular filling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mechanical ventilation
- And hemodynamic failure
- And decision of the attending physician to perform a vascular filling
Key exclusion criteria (2 listed)
- Pregnancy and breast-feeding women
- Patients deprived of their administrative or judicial freedom
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 |
|---|---|---|
| mitral dopplerMitral doppler before and after vascular filling | Diagnostic test | Mitral doppler |
Primary outcome
frequency of the occuring of premature degradation respiratory
Time frame: 30 minutes after vascular filling
definied by a reduction of at least 15% of the SpO2/FiO2 ratio in the 30min following the vascular filling
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 8 Oct 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mitral doppler in people with Respiration, Artificial and Vascular Filling, run by Centre Hospitalier Metropole Savoie at 3 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 3 inclusion and 2 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 8 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 3 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?
frequency of the occuring of premature degradation respiratory (time frame: 30 minutes after vascular filling). 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 8 Oct 2026.