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OpenTrials
Completed

NCT Number: NCT03763773

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

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.

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Key information

Conditions

Acute Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Roger Salengro, CHU

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. number of patient of death

    Time frame: At 28 days, at 90 days

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: PreMiTE-ARDS

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 4, 2018
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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