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

NCT ID: NCT03763773

Last Updated: 2022-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-21

Study Completion Date

2021-04-20

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Respiratory Distress Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sébastien Preau, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hôpital Roger Salengro, CHU

Lille, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 40312326 (View on PubMed)

Other Identifiers

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2018-A01463-52

Identifier Type: OTHER

Identifier Source: secondary_id

2017_30

Identifier Type: -

Identifier Source: org_study_id

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