Reliability of Echocardiography From Subcostal View

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: Unknown
• Conditions: Transthoracic Echocardiography
• Intervention / Treatment: Diagnostic test: Transthoracic echocardiography

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: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

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

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

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

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

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.	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.	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

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.	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.	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

• Sponsor: Emergency Medical Service of the Central Bohemian Region, Czech Republic
• Collaborators: Masaryk Hospital Usti nad Labem
• Investigators: Principal Investigator: Roman Skulec, MD, PhD, Masaryk Hospital Usti nad Labem

Publications and helpful links

General Publications

• Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2015 Jan;28(1):1-39.e14. doi: 10.1016/j.echo.2014.10.003.

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2020
• Primary Completion (Anticipated): July 28, 2021
• Study Completion (Anticipated): October 31, 2021

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (Actual): July 31, 2020

Study Record Updates

• Last Update Posted (Actual): August 24, 2020
• Last Update Submitted That Met QC Criteria: August 20, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID 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