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Clinical Trials/NCT06366061
NCT06366061
Recruiting
Not Applicable

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

Eckhard Mauermann1 site in 1 country100 target enrollmentMay 14, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Functional Disturbances During Surgery
Sponsor
Eckhard Mauermann
Enrollment
100
Locations
1
Primary Endpoint
S'Tissue Doppler Index (TDI) AP4C supine vs. S'STE SC4C supine
Status
Recruiting
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
May 14, 2022
End Date
December 1, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Eckhard Mauermann
Responsible Party
Sponsor Investigator
Principal Investigator

Eckhard Mauermann

PD

University Hospital, Basel, Switzerland

Eligibility Criteria

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

Outcomes

Primary Outcomes

S'Tissue Doppler Index (TDI) AP4C supine vs. S'STE SC4C supine

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

- Comparison of two velocities measured by two different methods.

Secondary Outcomes

  • 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))

Study Sites (1)

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