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

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Recruiting

CT.gov ID

NCT05452044

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

51 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Outcome Measures

Primary Outcome Measures

Displacement TAPSE [25 minutes]
Displacement (TAPSE) measured by: TAPSE STE, SC4C, Supine TAPSE MMODE, AP4C, LLD

Secondary Outcome Measures

Velocity (S') [25 minutes]
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

Other Outcome Measures

Reproducibility [25 minutes]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Basel	Basel		Switzerland	4056

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

University Hospital, Basel, Switzerland

ClinicalTrials.gov Identifier:

NCT05452044

Other Study ID Numbers:

ID 2020-02841

First Posted:

Jul 11, 2022

Last Update Posted:

Jul 11, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 11, 2022