Focus Cardiac Ultrasound in Patients With Shock (echoshock)

July 19, 2019 updated by: Nantes University Hospital

Focus Cardiac Ultrasound in Patients With Undifferentiated Shock: Prospective Observational Study

The aim of this study is to analyze in patients with undifferentiated shock, the concordance of initial treatment before and after Focus cardiac ultrasound (FoCUS) in comparison with the reference one established by an adjudication committee

Study Overview

Status

Unknown

Conditions

Detailed Description

Focus cardiac ultrasound (FoCUS) has already demonstrated its ability to reduce diagnosis uncertainty in patients with undifferentiated shock. However, adequacy of initial treatment has not been investigated.

In patients with undifferentiated shock, after clinical evaluation, the physician states its hypothesis and initial treatment intention in closed list. He realizes a FoCUS, states another time the hypothesis and begins treatment according to FoCUS results. An adjudication committee with all the patient's file will state the reference hypothesis and treatment

Study Type

Observational

Enrollment (Anticipated)

84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with undifferentiated shock in the Emergency Department

Description

Inclusion Criteria:

  • Undifferentiated shock defined by systolic arterial pressure < 90 mm Hg

Exclusion Criteria:

  • hemorrhagic shock
  • cardiac arrest
  • anaphylactic shock
  • documented end-of-life

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
concordance of initial treatment after FoCUS with Kappa coefficient
Time Frame: Hospitalization duration, up to one month
concordance between initial treatment after clinical procedure, after FoCUS in comparison with the reference stated by the adjudication committee with Kappa coefficient
Hospitalization duration, up to one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of FoCUS
Time Frame: Hospitalization duration, up to one month
concordance between initial diagnosis after clinical procedure, after FoCUS in comparison with the reference stated by the adjudication committee
Hospitalization duration, up to one month
difficulty of FoCUS
Time Frame: Hospitalization duration, up to one month
concordance between initial diagnosis after clinical procedure, after FoCUS in comparison with the reference stated by the adjudication committee
Hospitalization duration, up to one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

July 16, 2019

First Submitted That Met QC Criteria

July 19, 2019

First Posted (Actual)

July 22, 2019

Study Record Updates

Last Update Posted (Actual)

July 22, 2019

Last Update Submitted That Met QC Criteria

July 19, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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