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A Comparison of Right Ventricular Function in the Apical and Subcostal 4 Chamber TTE Views in the Perioperative Setting

NCT ID: NCT05452044

Last Updated: 2022-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-08

Study Completion Date

2022-12-31

Brief Summary

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The investigators would like to investigate whether angle-independent measurements of the heart's function can be made with the help of new computer programs and modern ultrasound devices. Furthermore, it will be checked whether and to what extent the patient's body position and general anesthesia have an influence on the ultrasound measurements.

Detailed Description

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Measuring right ventricular function is difficult on account of the ventricles shape, position, and mode of contraction. In transthoracic echocardiography a number of measures are endorsed by current guidelines, including: tricuspid annular plane systolic excursion (TAPSE), tricuspid annular plane velocities (S'), the right ventricular myocardial performance index (MPI), and fractional area change (FAC). Clinically, assessment is usually limited to measuring TAPSE by M-Mode or S' by tissue Doppler imaging, both of which are angle dependent technologies, but unlike the RV MPI or FAC are quick and easy to measure.

In the perioperative period, however, transthoracic echocardiography may be challenging for a number of reasons. First, obtaining usable apical 4-chamber (AP4C) images - the view used to measure TAPSE and S' - may be difficult in ventilated or post-surgical patients; subcostal 4-chamber views (SC4C), however, are generally obtainable. Secondly, gold standard images of the RV function are generally measured in the left lateral decubitus position, rather than supine, as is usually the case perioperative.

Newer technologies - such as speckle-tracking and 3D imaging - may partially overcome these difficulties as these technologies are considered to be relatively angle independent. For example, speckle-tracking can also measure TAPSE and S' and 3D imaging has been shown to correlated very well with MRI, the gold-standard for volume measurements.

This study aims at examining the bias, precision, and reproducibility of speckle-tracking based TAPSE and S' (TAPSESTE and S'STE) measured in the SC4C with measurements of TAPSE by M-Mode and S' TDI (TAPSEM-MODE and S'TDI) in the left lateral decubitus position. Secondly, the investigators will compare measures of RV function made in the supine position to those in the left lateral decubitus position to ascertain the relevance of positioning in the perioperative setting. Patients will have measurements made before and after induction of anaesthesia.

The investigators hypothesize that TAPSE measured by STE in the SC4C with the patient in supine position(TAPSE STE, SC4C, Supine) will be sufficiently similar to TAPSE measured by M-MODE in the AP4C with the patient in the left lateral decubitus position (TAPSE MMODE, AP4C, LLD). A similar hypothesis holds for S' (S' STE, SC4C, Supine and S' TDI, AP4C, LLD).

Conditions

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Assessment of Right Ventricular Function

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Consenting, adult, in-patients undergoing surgery

Exclusion Criteria

* Inability to follow the procedures of the study, e.g. due to language problems, vulnerable population, illiterate populations, incompetent/incapacitated adults, -psychological disorders, dementia,
* Previous enrolment into the current study,
* Emergency procedures mandating expeditive patient care,
* Non regular heart rhythm
* Documented valvular heart disease in the RV at least midgrade
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eckhard Mauermann, MD, M.Sc

Role: STUDY_DIRECTOR

University Hospital Basel Department for Anaesthesia

Locations

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University Hospital Basel

Basel, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Eckhard Mauermann, MD, M.Sc

Role: CONTACT

Phone: +4161 265 74 24

Email: [email protected]

Facility Contacts

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Eckhard Mauermann, Dr. med. MD

Role: primary

Related Links

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https://www.admin.ch/opc/en/classified-compilation/20121177/index.html

Ordinance on Human Research with the Exception of Clinical trials (HRO)

http://www.admin.ch/opc/en/classified-compilation/20121176/201401010000/810.305.pdf

Human Research Act (HRA)

https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects

Declaration of Helsinki

http://www.jclinepi.com/article/S0895-4356(07)00436-2/pdf

STROBE statement

Other Identifiers

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ID 2020-02841

Identifier Type: -

Identifier Source: org_study_id