Evaluation of Right Ventricular Systolic Function by TAPSE Parameter From Subcostal View

Echocardiographic Evaluation of Right Ventricular Systolic Function by TAPSE Parameter Measured From Subcostal View Using Anatomical M-mode - Validation Clinical Study

The purpose of this study is to validate a new echocardiographic parameter evaluating right ventricular function.

Study Overview

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

Detailed Description

The key conventional echocardiographic parameter evaluating right ventricular systolic function is the tricuspid annular plane systolic excursion (TAPSE). It is measured in apical four chamber view by conventional M-mode imaging. Other echocardiographic parameters of right ventricular systolic function (Fractional Area Change; Tricuspid Lateral Annular Systolic Velocity; Right Ventricular Index of Myocardial Performance) are evaluated in apical four chamber view as well. However, this view might not be clearly visible in the clinical setting of critical illness and subcostal view is often preferred for its higher quality. Unfortunately, conventional M-mode can not be used for measurement in this view but anatomical M-mode imaging can. Therefore, the investigators decided to evaluate whether TAPSE measured in subcostal view by anatomical M-mode (sTAPSE) correlates with conventional TAPSE and whether reliably reflects systolic right ventricular function.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Roman Skulec, MD, PhD; Phone Number: 00420777577497; Email: skulec@email.cz
• Study Contact Backup: Name: Tomas Parizek, MD; Phone Number: 00420603187997; Email: parizek.t1@gmail.com

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 intensive care unit 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?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Critically ill patients; Critically ill patients hospitalised at the intensive care unit indicated to echocardiographic examination.	Diagnostic test: Transthoracic echocardiography; Conventional transthoracic echocardiographic examination at the intensive care unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validity of sTAPSE in prediction of right ventricular systolic dysfunction	sTAPSE is a new potential echocardiographic parameter of right ventricular systolic function measurable from subcostal view.	During the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of sTAPSE with conventional TAPSE	sTAPSE is a new potential echocardiographic parameter of right ventricular systolic function measurable from subcostal view.	During the intervention

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. Eur Heart J Cardiovasc Imaging. 2015 Mar;16(3):233-70. doi: 10.1093/ehjci/jev014. Erratum In: Eur Heart J Cardiovasc Imaging. 2016 Apr;17(4):412. Eur Heart J Cardiovasc Imaging. 2016 Sep;17 (9):969.

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2020
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): October 31, 2020

Study Registration Dates

• First Submitted: July 19, 2020
• First Submitted That Met QC Criteria: July 26, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Actual): August 19, 2020
• Last Update Submitted That Met QC Criteria: August 18, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Murmurs; Systolic Murmurs
• Other Study ID Numbers: 284/34

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