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Trial record 19 of 198 for:    Recruiting, Not yet recruiting, Available Studies | Neonatal respiratory distress syndrome

Prediction of Outcomes With a Miniaturized Transesophageal Echocardiography Probe in Patients With Acute Respiratory Distress Syndrome (PreMiTE-ARDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03763773
Recruitment Status : Recruiting
First Posted : December 4, 2018
Last Update Posted : July 11, 2019
Information provided by (Responsible Party):
University Hospital, Lille

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.

Condition or disease
Acute Respiratory Distress Syndrome

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction of Outcomes With a Miniaturized Transesophageal Echocardiography Probe in Patients With Acute Respiratory Distress Syndrome
Actual Study Start Date : April 21, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Primary Outcome Measures :
  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 Outcome Measures :
  1. number of patient of death [ Time Frame: At 28 days, at 90 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with mechanical ventilation hospitalized in intensive care, emergency or intensive care units

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03763773

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Contact: Sébastien Preau, MD ext +33

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Hôpital Roger Salengro, CHU Recruiting
Lille, France
Principal Investigator: Sébastien Preau, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
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Principal Investigator: Sébastien Preau, MD University Hospital, Lille

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Responsible Party: University Hospital, Lille Identifier: NCT03763773     History of Changes
Other Study ID Numbers: 2017_30
2018-A01463-52 ( Other Identifier: ID-RCB number, ANSM )
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
respiratory variations,
superior vena cava
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Tract Diseases
Infant, Newborn, Diseases
Acute Lung Injury
Pathologic Processes
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Lung Injury