Clinical trial NCT04490538: Evaluation of Right Ventricular Systolic Function by TAPSE Parameter From Subcostal View
Official title: Echocardiographic Evaluation of Right Ventricular Systolic Function by TAPSE Parameter Measured From Subcostal View Using Anatomical M-mode - Validation Clinical Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Transthoracic Echocardiography
Lead sponsor: Emergency Medical Service of the Central Bohemian Region, Czech Republic
Sponsor class: OTHER
Collaborators: name: Masaryk Hospital Usti nad Labem
First posted: 2020-07-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult intensive care unit patients.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Validity of sTAPSE in prediction of right ventricular systolic dysfunction
timeFrame: During the intervention
Secondary outcomes:
measure: Correlation of sTAPSE with conventional TAPSE
timeFrame: During the intervention
Other outcomes:
Locations:
city: Usti nad Labem
country: Czechia
facility: Masaryk Hospital Usti nad Labem
Study officials:
affiliation: Masaryk Hospital Usti nad Labem
name: Roman Skulec, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.