Prediction of Outcomes With a Miniaturized Transesophageal Echocardiography Probe in Patients Wit… (NCT03763773) | Clinical Trial Compass
CompletedNot Applicable
Prediction of Outcomes With a Miniaturized Transesophageal Echocardiography Probe in Patients With Acute Respiratory Distress Syndrome
France50 participantsStarted 2019-04-21
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of days lived without mechanical ventilation