NCT02974790

Brief Summary

After a basic training to echocardiography, emergency physicians will have to answer simple clinical questions about circulatory failure mechanisms. The objective of the study is to assess the agreement between these answers and those of the expert physician in patients admitted in the emergency department with a circulatory failure due to sepsis or not. Emergency physicians will volunteer to take part in a basic training on echocardiography. The training will include 4 hours of theory, 2 hours of interactive clinical cases and 6 hours of tutored practice at patients' bedside (10 to 15 examinations). The objective of the practice sessions will be to learn the technical grounds of transthoracic echocardiography (TTE), the different views and to identify the anatomical structures. The second part of the study will start after the training. Each eligible patient will be successively assessed by two investigators: one emergency physician recently trained and the expert physician. The echocardiography will be performed as soon as possible in the emergency department before or after the initiation of treatment without delaying it. The order of hemodynamic assessments will be random depending on the availability of the investigators; both assessments will however be performed within 30 minutes. Each investigator will independently read the echocardiography in real time at patients' bedside. They will then answer a limited list of standardized questions using two-choice answers or predefined choices. Finally investigators will choose a therapeutic proposition among a predefined list based on the answers. Only the results of the echocardiography performed by the expert physician will be used in patient management.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 28, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

January 2, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2018

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

1 year

First QC Date

November 23, 2016

Last Update Submit

March 27, 2018

Conditions

Keywords

echocardiographytrainingemergency departmentcirculatory failure

Outcome Measures

Primary Outcomes (1)

  • Agreement between emergency physician and referee physician echocardiography

    Agreement between the measurements performed using two-dimensional imaging echocardiography by an emergency physician and the referring physician according to the following data : * size of the left ventricle * systolic function of the left ventricle * size of the right ventricle * dysfunction of the right ventricle * size of the inferior vena cava pericardial effusion

    Day 1

Secondary Outcomes (1)

  • Agreement between emergency physicians and referring physician therapeutic propositions

    Day 1

Study Arms (1)

Circulatory failure

Patients with a circulatory failure due to a sepsis or not

Procedure: Echocardiography

Interventions

Two-dimensional imaging echocardiography

Circulatory failure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hemodynamic assessment will target patients with circulatory failure and / or sepsis in emergency unit

You may qualify if:

  • patients \> 18 years old
  • patients admitted in the Emergency Department of Limoges University Hospital
  • patients with circulatory failure defined as 1 or more of the following criteria :
  • clinical signs of tissue hypoperfusion
  • mottling
  • Encephalopathy
  • Oliguria \< 0.5 ml/kg/h
  • biological signs of hypoperfusion
  • Lactate \> 2 mmol/L
  • AND/OR Low blood pressure defined as a sBP \< 90 mmHg or mBP \< 65 mmHG or decrease of sBP \> 40 mmHg compared with usual blood pressure
  • OR Patients with signs of sepsis recently defined as the following :
  • Suspicion of clinical infection
  • At least 2 of the 3 following items (i.e. SOFA \> 2 points with 1 point/item) :
  • Glasgow score \< 13
  • Respiratory rate \> 22 cycle/min
  • +1 more criteria

You may not qualify if:

  • Pregnant patients
  • Moribund patients or with limited care
  • Patients under legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Limoges University Hospital

Limoges, 87042, France

Location

MeSH Terms

Conditions

ShockEmergencies

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Design

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

Study Record Dates

First Submitted

November 23, 2016

First Posted

November 28, 2016

Study Start

January 2, 2017

Primary Completion

January 2, 2018

Study Completion

March 2, 2018

Last Updated

March 29, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations