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

Cardiac Functional Disturbances During Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06366061
• Other study ID #: 2020-02868
• Status: Recruiting
• Start date: May 14, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: April 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Michael Lampart, Prakt. med.
• Phone: +41 61 328 64 77
• Email: michael.lampart[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Functional Disturbances During Surgery

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel	Basel Stadt

Sponsors (1)

Lead Sponsor	Collaborator
Eckhard Mauermann

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Primary	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	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)