Diagnostic Performance of Echocardiography Performed by Emergency Physicians After a Basic Training

Echocardiography Clinical Trial

— ECHOBEDSIDE  

Official title:

Diagnostic Performance of Echocardiography Performed by Emergency Physicians After a Basic Training

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02974790
• Other study ID #: I16035 (ECHOBEDSIDE)
• Status: Terminated
• 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
• 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

Related Conditions & MeSH terms

• Circulatory Failure
• Echocardiography
• Emergencies
• Shock

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