A COMPARISON OF LEFT VENTRICULAR FUNCTION IN THE APICAL 4 CHAMBER AND SUBCOSTAL 4 CHAMBER TTE VIEWS IN THE PERIOPERATIVE SETTING

A COMPARISON OF LEFT VENTRICULAR FUNCTION IN THE APICAL 4 CHAMBER AND SUBCOSTAL 4 CHAMBER TTE VIEWS IN THE PERIOPERATIVE SETTING: A PROSPECTIVE, CLINICAL TRIAL

This study aims to examine the correlation and agreement of regional and global measurements of ventricular function in the apical 4 chamber and subcostal 4 chamber view. Additionally, we will explore limitations of the technology and explore the effect of left lateral positioning.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Functional Disturbances During Surgery

Detailed Description

In transthoracic echocardiography, a number of measures are endorsed by current guidelines for quantifying ventricular function. These include conventional (mitral annular plane velocities, ejection fraction) and novel, speckle-tracking (STE) technologies. However, these measurements are standardized to be measured in the left lateral decubitus position in the apical (4-chamber) view of awake spontaneously breathing patients.

In the perioperative period, however, attaining these measurements in the endorsed circumstances may be challenging for a number of reasons. First, obtaining usable AP4C images may be difficult in ventilated or post-surgical patients. While the SC4C is generally obtainable visualized structures are not identical to those of the AP4C and measurement technologies such as Doppler are misaligned Secondly, patient conditions (e.g. in distress, or during surgery) may preclude positioning the patient in the left lateral decubitus position. Finally, patients may be ventilated and under anesthesia.

Newer technologies - such as speckle-tracking- may partially overcome these difficulties as these technologies are considered to be relatively angle independent. For quantification, it would be important to know whether or not speckle-tracking based measurements in the SC4C are sufficiently close to those measured under the endorsed conditions.

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

Contacts and Locations

• Study Contact: Name: Michael Lampart, Prakt. med.; Phone Number: +41 61 328 64 77; Email: michael.lampart@usb.ch
• Study Contact Backup: Name: Eckhard Mauermann, PD; Phone Number: +41 61 328 73 87; Email: eckhard.mauermann@usb.ch

Study Locations

• Switzerland
  • Basel Stadt
    • Basel, Basel Stadt, Switzerland, 4000
      • Recruiting
      • University Hospital Basel
      • Contact: Michael Lampart, Prakt. med.; Phone Number: +41764006180; Email: michael.lampart@usb.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing elective non-cardiac surgery

Description

Inclusion Criteria:

• Consenting adult patients undergoing elective non-cardiac surgery

Exclusion Criteria:

• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
• Previous enrolment into the current study,
• Emergency procedures mandating expeditive patient care,
• Nonregular heart rhythm
• Valvular heart disease in the LV at least midgrade

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Randomization; A randomization will be done for the order of the different TTE measurments, but all patients are going the same TTE measurements after all

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
S'Tissue Doppler Index (TDI) AP4C supine vs. S'STE SC4C supine	- Comparison of two velocities measured by two different methods.	This is going to be assessed after the trans thoracic echocardiography, through study completion (an average of 1 year)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global longitudinal strain (GLS), AP4C supine vs. GLS, SC4C supine, i.e. clinical questions: can we use the SC4C for global markers of ventricular function?	Correlation: GLS, AP4C, supine vs. GLS, SC4C supine; Bland Altman (BA) Plot: GLS, AP4C, supine vs. GLS, SC4C supine	This is going to be assessed after the trans thoracic echocardiography, through study completion (an average of 1 year)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of high Frame Rate (FR) vs. low FR of the following measures: [ i) S'STE AP4C supine, ii) GLS AP4C supine, iii) SR AP4C supine]	With high Frame Rate (FR) the measures will be more exact than with low FR	This is going to be assessed after the trans thoracic echocardiography, through study completion (an average of 1 year)
Comparison of the measured values in the cardiological gold standard (Left lateral decubitus (LLD)) vs. supine, for the following values [ i) S'TDI AP4C, ii) S'STE AP4C, iii) GLS]	Comparison of values in different patient position for TTE	This is going to be assessed after the trans thoracic echocardiography, through study completion (an average of 1 year)

Collaborators and Investigators

• Sponsor: Eckhard Mauermann

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2022
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 13, 2022
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Estimated): April 15, 2024

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2020-02868

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