A Comparison of Right Ventricular Function in the Apical and Subcostal 4 Chamber TTE Views in the Perioperative Setting

A Comparison of Right Ventricular Function in the Apical 4 Chamber and Subcostal 4 Chamber TTE Views in the Perioperative Setting: A Prospective Clinical Study

The investigators would like to investigate whether angle-independent measurements of the heart's function can be made with the help of new computer programs and modern ultrasound devices. Furthermore, it will be checked whether and to what extent the patient's body position and general anesthesia have an influence on the ultrasound measurements.

Study Overview

• Status: Recruiting
• Conditions: Assessment of Right Ventricular Function

Detailed Description

Measuring right ventricular function is difficult on account of the ventricles shape, position, and mode of contraction. In transthoracic echocardiography a number of measures are endorsed by current guidelines, including: tricuspid annular plane systolic excursion (TAPSE), tricuspid annular plane velocities (S'), the right ventricular myocardial performance index (MPI), and fractional area change (FAC). Clinically, assessment is usually limited to measuring TAPSE by M-Mode or S' by tissue Doppler imaging, both of which are angle dependent technologies, but unlike the RV MPI or FAC are quick and easy to measure.

In the perioperative period, however, transthoracic echocardiography may be challenging for a number of reasons. First, obtaining usable apical 4-chamber (AP4C) images - the view used to measure TAPSE and S' - may be difficult in ventilated or post-surgical patients; subcostal 4-chamber views (SC4C), however, are generally obtainable. Secondly, gold standard images of the RV function are generally measured in the left lateral decubitus position, rather than supine, as is usually the case perioperative.

Newer technologies - such as speckle-tracking and 3D imaging - may partially overcome these difficulties as these technologies are considered to be relatively angle independent. For example, speckle-tracking can also measure TAPSE and S' and 3D imaging has been shown to correlated very well with MRI, the gold-standard for volume measurements.

This study aims at examining the bias, precision, and reproducibility of speckle-tracking based TAPSE and S' (TAPSESTE and S'STE) measured in the SC4C with measurements of TAPSE by M-Mode and S' TDI (TAPSEM-MODE and S'TDI) in the left lateral decubitus position. Secondly, the investigators will compare measures of RV function made in the supine position to those in the left lateral decubitus position to ascertain the relevance of positioning in the perioperative setting. Patients will have measurements made before and after induction of anaesthesia.

The investigators hypothesize that TAPSE measured by STE in the SC4C with the patient in supine position(TAPSE STE, SC4C, Supine) will be sufficiently similar to TAPSE measured by M-MODE in the AP4C with the patient in the left lateral decubitus position (TAPSE MMODE, AP4C, LLD). A similar hypothesis holds for S' (S' STE, SC4C, Supine and S' TDI, AP4C, LLD).

• Study Type: Observational
• Enrollment (Anticipated): 51

Contacts and Locations

• Study Contact: Name: Eckhard Mauermann, MD, M.Sc; Phone Number: +4161 265 74 24; Email: Eckhard.mauermann@gmail.com

Study Locations

• Switzerland
  • Basel, Switzerland, 4056
    • Recruiting
    • University Hospital Basel
    • Contact: Eckhard Mauermann, Dr. med. MD; Phone Number: +4161 265 74 24; Email: Eckhard.mauermann@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgery

Description

Inclusion Criteria:

• Consenting, adult, in-patients undergoing surgery

Exclusion Criteria:

• Inability to follow the procedures of the study, e.g. due to language problems, vulnerable population, illiterate populations, incompetent/incapacitated adults, -psychological disorders, dementia,
• Previous enrolment into the current study,
• Emergency procedures mandating expeditive patient care,
• Non regular heart rhythm
• Documented valvular heart disease in the RV at least midgrade

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Displacement TAPSE	Displacement (TAPSE) measured by: TAPSE STE, SC4C, Supine TAPSE MMODE, AP4C, LLD	25 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Velocity (S')	TAPSE STE and TAPSEMMODE both in the AP4C, but supine vs. in left lateral decubitus position. The effect of frame rate on S'STE measurements	25 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reproducibility	Correlation of TAPSESTE and S'STE with strain, strain rate, fractional area change (FAC), and right ventricular ejection fraction by 3D. Reproducibility of TAPSE and S' measurements by ICC	25 minutes

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Study Director: Eckhard Mauermann, MD, M.Sc, University Hospital Basel Department for Anaesthesia

Publications and helpful links

Helpful Links

• Ordinance on Human Research with the Exception of Clinical trials (HRO)
• Human Research Act (HRA)
• Declaration of Helsinki
• STROBE statement

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: ID 2020-02841

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD Plan Description

All measurements first are going to be written down on the CRF. After this we are going to enter the data in the system (Redcap®). All written CRF's are then stored in a locked room of the research groups for ten years. After every 10th patient an otherwise uninvolved study nurse will compare the datebase entry in RedCap, the CRF, and the source documents.

If the findings are insufficient, more frequent checks will occur. Source docs are: premedication documentation, anesthesia record, echo measurement documentation (CRF). These will also be stored in the locked premises of the research group.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No