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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02974790
Other study ID # I16035 (ECHOBEDSIDE)
Secondary ID
Status Terminated
Phase
First received November 23, 2016
Last updated March 27, 2018
Start date January 2, 2017
Est. completion date March 2, 2018

Study information

Verified date March 2018
Source University Hospital, Limoges
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Terminated
Enrollment 89
Est. completion date March 2, 2018
Est. primary completion date January 2, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

- Systolic blood pressure < 100 mmHg

Exclusion Criteria:

- Pregnant patients

- Moribund patients or with limited care

- Patients under legal protection

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Echocardiography
Two-dimensional imaging echocardiography

Locations

Country Name City State
France Limoges University Hospital Limoges

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Limoges CIC 1415 INSERM - Tours University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Agreement between emergency physicians and referring physician therapeutic propositions Agreement between emergency physicians and referring physician therapeutic propositions according to the following choices:
vascular filling define as a water volume of at least 500 mL
vasopressor support
positive inotropic therapy
salt and water depletion
Day 1
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