Reliability of Echocardiography From Subcostal View

August 20, 2020 updated by: Roman Skulec, Emergency Medical Service of the Central Bohemian Region, Czech Republic

Reliability of Echocardiographic Assessment of Cardiac Dimensions and Function From Subcostal View

The purpose of this study is to assess reliability of echocardiographic assessment of ventricular dimensions and function from subcostal view.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Assessment of the function and dimensions of the right and left ventricles is a key part of Point-of-Care ultrasound in critically ill patients. According to the recent guidelines, this evaluation is performed from apical and parasternal views. However, these views may not be clearly visible in the clinical setting of critical illness and subcostal view is often preferred for its higher feasibility. Before clinical adoption, it is necessary to assess whether the isolated examination from subcostal view is reliable enough in the detection of the impairment of systolic function and the size of both ventricles and the investigators decided to evaluate this issue.

Transverse and longitudinal dimensions and function of both ventricles will be measured calculated by transthoracic echocardiography in critically ill patients in the intensive care unit from parasternal and apical views following the recent guidelines. Systolic function of the left ventricle will be expressed by the left ventricular ejection fraction (calculated by biplane method of disc summation) and by the fraction shortening. Systolic function of the right ventricle will be assessed by the tricuspid annular plane systolic excursion, fractional area change, tricuspid lateral annular systolic velocity, and right ventricular index of myocardial performance. From subcostal view, transverse dimensions of both ventricles and novel parameters of systolic function (subcostal tricuspid annular plane systolic excursion, right ventricular subcostal fraction shortening, right ventricular modified subcostal fraction shortening, left ventricular subcostal fraction shortening and left ventricular modified fraction shortening) will be measured.

Then, the reliability of parameters measured in subcostal view will be tested by comparison with conventional parameters taken from apical and parasternal view by correlation analysis and diagnostic test evaluation. The most reliable thresholds of parameters from subcostal view will be calculated by receiver operating characteristic analysis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Roman Skulec, MD, PhD
  • Phone Number: 00420777577497
  • Email: skulec@email.cz

Study Contact Backup

Study Locations

  • Czechia
      • Usti nad Labem, Czechia, 40113
        • Recruiting
        • Masaryk Hospital Usti nad Labem
        • Contact:
          • Roman Skulec, MD, PhD
          • Phone Number: 00420777577497
          • Email: skulec@email.cz

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Adult critically ill patients.

Description

Inclusion Criteria:

  • Inpatients
  • All patients hospitalised in intensive care unit indicated for transthoracic echocardiography examination

Exclusion Criteria:

  • Age <18 years
  • Insufficient imaging quality of transthoracic echocardiography
  • Refusal of echocardiographic examination by patient

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: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Critically ill patients
Adult critically ill patients hospitalised in the intensive care unit.
Diagnostic test: Transthoracic echocardiography
Standard Point-of-Care echocardiographic examination in the intensive care unit.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reliability of left ventricular subcostal fractional shortening and left ventricular modified subcostal fractional shortening in determining the global left ventricular systolic function in critically ill patients.
Time Frame: During the procedure
Left ventricular subcostal fractional shortening and left ventricular modified subcostal fractional shortening are new potential echocardiographic parameters of left ventricular systolic function measurable from subcostal view.
During the procedure
Reliability of right ventricular subcostal fractional shortening and right ventricular modified subcostal fractional shortening in determining the global right ventricular systolic function in critically ill patients.
Time Frame: During the procedure
Right ventricular subcostal fractional shortening and right ventricular modified subcostal fractional shortening are new potential echocardiographic parameters of right ventricular systolic function measurable from subcostal view.
During the procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reliability of echocardiographic parameters evaluating the structure of the left ventricle measured in a subcostal view in critically ill patients.
Time Frame: During the procedure
Quantification of the left ventricular structure (size and mass) is an important part of echocardiographic examination in critically ill patients. However, the reliability of these parameters measured in the subcostal projection has not been defined.
During the procedure
Reliability of echocardiographic parameters evaluating the size of the right ventricle measured in a subcostal view in critically ill patients.
Time Frame: During the procedure
Quantification of the right ventricular size is an important part of echocardiographic examination in critically ill patients. However, its reliability when measured in the subcostal projection has not been defined.
During the procedure

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emergency Medical Service of the Central Bohemian Region, Czech Republic

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Masaryk Hospital Usti nad Labem

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Roman Skulec, MD, PhD, Masaryk Hospital Usti nad Labem

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 20, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 28, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 02/2020

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings