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

NCT03763773 | Completed

• 2 other identifiers: 2017_302018-A01463-52
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

respiratory variations,; superior vena cava; prognosis.

Outcome Measures

Primary Outcomes (1)

• 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.

  at 28 days

Secondary Outcomes (1)

• number of patient of death

  At 28 days, at 90 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with mechanical ventilation hospitalized in intensive care, emergency or intensive care units

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Roger Salengro, CHU

Lille, France

Location

Related Publications (1)

• 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.

  PMID: 40312326 RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Sébastien Preau, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 4, 2018
• Study Start: April 21, 2019
• Primary Completion: April 20, 2021
• Study Completion: April 20, 2021
• Last Updated: April 22, 2026

Record last verified: 2022-04

Locations

FR (1)