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Prediction of Outcomes With a Miniaturized Transesophageal Echocardiography Probe in Patients With Acute Respiratory Distress Syndrome

Prediction of Outcomes With a Miniaturized Transesophageal Echocardiography Probe in Patients With Acute Respiratory Distress Syndrome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03763773
Acronym
PreMiTE-ARDS
Enrollment
50
Registered
2018-12-04
Start date
2019-04-21
Completion date
2021-04-20
Last updated
2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome

Keywords

respiratory variations,, superior vena cava, prognosis.

Brief 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.

Interventions

None listed

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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).

Exclusion criteria

* 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 * 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.

Design outcomes

Primary

MeasureTime frameDescription
Number of days lived without mechanical ventilationat 28 daysThis 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.

Secondary

MeasureTime frame
number of patient of deathAt 28 days, at 90 days

Countries

France

Contacts

PRINCIPAL_INVESTIGATORSébastien Preau, MD

University Hospital, Lille

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 23, 2026