Acute Respiratory Distress SyndromePreMiTE-ARDSNCT03763773
Prediction of Outcomes With a Miniaturized Transesophageal Echocardiography Probe in Patients With Acute Respiratory Distress Syndrome
An observational study of Acute Respiratory Distress Syndrome, run by University Hospital, Lille at 1 site in France.
Trial summary
The Superior Vena cava Respiratory Collapse Index (cVCS) is a haemodynamic parameter measured exclusively by transoesophageal ultrasound (TEE), which is used to assess cardiac precharge-dependence status. This may be an important prognostic factor in ARDS because it is a sign of hypervolemia and right heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 21 Apr 2019to 20 Apr 2021
- Phase
- Observational
- 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
Study population: patients with mechanical ventilation hospitalized in intensive care, emergency or intensive care units
Who may be able to join
- Patients hospitalized in Resuscitation, Emergency or Intensive Care Units at the Roger Salengro Hospital at Lille University Hospital.
- With acute respiratory distress syndrome of intermediate or severe severity (1) for less than 24 hours.
- Mechanical ventilation with tracheal intubation or tracheostomy, in controlled assisted ventilation (VAC) mode.
- Patient adapted to mechanical ventilation (no triggering of spontaneous ventilation cycle in VAC mode verified by the equality between the respiratory rate prescribed on the ventilator and the actual respiratory rate of the patient).
Who cannot join
- Patient under extracorporeal respiratory assistance at the time of inclusion.
- Anomalies or pathologies that make it dangerous or impossible to introduce an ETO probe:
- Fistula, perforation, stenosis, varicose vein or diverticulum of the esophagus and / or stomach
- History of esophageal and / or gastric surgery
- Caustic lesions of the esophagus and / stomach
- Tumor or history of oropharyngeal surgery
Show all 11Show fewer
- Unstable lesions of the cervical spine
- Coagulopathy (thrombocytopenia <50 109 / L and / or TP <50%).
- Impossibility of measuring the diameter of the superior vena cava and cVCS in ETO due to poor echogenicity.
- Pregnant woman.
- Therapeutic limitation measures limiting the treatment of organ failure.
Trial locations and contacts
1 site in 1 country.
About this study
The Superior Vena cava Respiratory Collapse Index (cVCS) is a haemodynamic parameter measured exclusively by transoesophageal ultrasound (TEE), which is used to assess cardiac precharge-dependence status. This may be an important prognostic factor in ARDS because it is a sign of hypervolemia and right heart failure.
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- respiratory variations,, superior vena cava, prognosis.
- Medical subject headings
- Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days lived without mechanical ventilation
This variable will be defined as follows:duration = 28 -x -y. where x is the number of days living under mechanical ventilation during the first 28 days and the number of days in the first 28 days.
Measured: at 28 days
Secondary outcomes (1)
number of patient of death
Measured: At 28 days, at 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start21 Apr 2019
- Primary completion20 Apr 2021
- Study completion20 Apr 2021
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 Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien Preau, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763773
- Sponsor's protocol ID
- 2017_30
- Other IDs
- 2018-A01463-52
- Acronym
- PreMiTE-ARDS
- Status last verified
- Apr 2022
- First submitted
- 3 Dec 2018
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Preau S, Pouly O, Ederkaoui M, Durand A, Bourel C, Onimus T, Cadart L, Labreuche J, Howsam M, Favory R, Pierre A. Lack of preload responsiveness may determine poor clinical outcomes in mechanically ventilated patients with ARDS. Crit Care. 2025 May 1;29(1):172. doi: 10.1186/s13054-025-05409-4.
PubMed 40312326
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Outcomes With a Miniaturized Transesophageal Echocardiography Probe in Patients With Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT03763773
- Acronym / sponsor ID
- PreMiTE-ARDS / 2017_30
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- respiratory variations,, superior vena cava, prognosis.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 21 Apr 2019 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 4 Dec 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.
The Superior Vena cava Respiratory Collapse Index (cVCS) is a haemodynamic parameter measured exclusively by transoesophageal ultrasound (TEE), which is used to assess cardiac precharge-dependence status. This may be an important prognostic factor in ARDS because it is a sign of hypervolemia and right heart failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with mechanical ventilation hospitalized in intensive care, emergency or intensive care units
Key inclusion criteria (4 listed)
- Patients hospitalized in Resuscitation, Emergency or Intensive Care Units at the Roger Salengro Hospital at Lille University Hospital.
- With acute respiratory distress syndrome of intermediate or severe severity (1) for less than 24 hours.
- Mechanical ventilation with tracheal intubation or tracheostomy, in controlled assisted ventilation (VAC) mode.
- Patient adapted to mechanical ventilation (no triggering of spontaneous ventilation cycle in VAC mode verified by the equality between the respiratory rate prescribed on the ventilator and the actual respiratory rate of the patient).
Key exclusion criteria (11 listed)
- Patient under extracorporeal respiratory assistance at the time of inclusion.
- Anomalies or pathologies that make it dangerous or impossible to introduce an ETO probe:
- Impossibility of measuring the diameter of the superior vena cava and cVCS in ETO due to poor echogenicity.
- Pregnant woman.
- Therapeutic limitation measures limiting the treatment of organ failure.
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
Number of days lived without mechanical ventilation
Time frame: at 28 days
This variable will be defined as follows:duration = 28 -x -y. where x is the number of days living under mechanical ventilation during the first 28 days and the number of days in the first 28 days.
1 secondary outcome
number of patient of death
Time frame: At 28 days, at 90 days
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 22 Apr 2026.
- Results publication: PubMed 40312326Preau S, Pouly O, Ederkaoui M, Durand A, Bourel C, Onimus T, Cadart L, Labreuche J, Howsam M, Favory R, Pierre A. Lack of preload responsiveness may determine poor clinical outcomes in mechanically ventilated patients with ARDS. Crit Care. 2025 May 1;29(1):172. doi: 10.1186/s13054-025-05409-4.
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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.
Sébastien Preau, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome, run by University Hospital, Lille at 1 site 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 11 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 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of days lived without mechanical ventilation (time frame: at 28 days). 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 NCT03763773, 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 22 Apr 2026.