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

NCT06366061 | Recruiting

• 1 other identifier: 2020-02868
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Functional Disturbances During Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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?

  This is going to be assessed after the trans thoracic echocardiography, through study completion (an average of 1 year)

Other Outcomes (2)

• 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]

  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]

  This is going to be assessed after the trans thoracic echocardiography, through study completion (an average of 1 year)

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing elective non-cardiac surgery

You may qualify if:

• Consenting adult patients undergoing elective non-cardiac surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Eckhard Mauermann: lead

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4000, Switzerland

RECRUITING

Central Study Contacts

Michael Lampart, Prakt. med.

CONTACT

+41 61 328 64 77; michael.lampart@usb.ch

Eckhard Mauermann, PD

CONTACT

+41 61 328 73 87; eckhard.mauermann@usb.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: April 15, 2024
• Study Start: May 14, 2022
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)