Clinical trial NCT06366061: A COMPARISON OF LEFT VENTRICULAR FUNCTION IN THE APICAL 4 CHAMBER AND SUBCOSTAL 4 CHAMBER TTE VIEWS IN THE PERIOPERATIVE SETTING
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Functional Disturbances During Surgery
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing elective non-cardiac surgery

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.

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

Primary outcomes:
measure: S'Tissue Doppler Index (TDI) AP4C supine vs. S'STE SC4C supine
timeFrame: This is going to be assessed after the trans thoracic echocardiography, through study completion (an average of 1 year)
Secondary outcomes:
measure: 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?
timeFrame: This is going to be assessed after the trans thoracic echocardiography, through study completion (an average of 1 year)
Other outcomes:
measure: 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]
timeFrame: This is going to be assessed after the trans thoracic echocardiography, through study completion (an average of 1 year)
measure: 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]
timeFrame: This is going to be assessed after the trans thoracic echocardiography, through study completion (an average of 1 year)
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: Basel Stadt
Study officials:
References: