Clinical trial NCT05193760: Robustness Check of Placement and Measurement Algorithms for Blood Flow Measurement on Common Carotid Artery
Official title: Robustness Check of Placement and Measurement Algorithms for Blood Flow Measurement on Common Carotid Artery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Aortic Valve Disease
Mitral Valve Disease
Keywords: Common carotid artery
Ultrasound
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
Collaborators: name: Philips Electronics Nederland BV
First posted: 2022-01-18
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult (\>18 years) cardiac surgery or TAVI patients.

Brief summary: This study is set up to test the robustness of algorithms and models and to optimize them. Furthermore, data are used to investigate the influence of probe orientation on parameters of the common carotid artery.

Detailed description: This study has four objectives:

1. Determine the robustness of the placement and measurement algorithms with ultrasound images, obtained with different ultrasound system settings and probe movements.
2. Verificate and optimize the arterial blood flow model.
3. Determine the variation in location and size of the arteries and veins in the area around the common carotid artery.
4. Determine the influence of probe orientation on parameters obtained from ultrasound measurements of the common carotid artery.

Sample size and missing data Due to limited time in the operating room, the measurement protocol is divided into four parts. Per protocol part data of 25 patients is deemed sufficient to be able to answer the above-mentioned objectives, which would result in a total of 100 inclusions. However, the investigators expect to perform more than one measurement protocol per patient, due to which a total of 75 inclusions is needed. Patients of whom the data is qualitatively too low to be used for analysis will be replaced. As such, the investigators make sure to have qualitatively good data of 25 patients per protocol part.

Eligibility criteria: Inclusion Criteria:

* Adult (\>18 years) patients.
* Participant should be able to provide informed consent in Dutch.

Exclusion Criteria:

* Participant has a known stenosis of the carotid artery.
* Patient has open wounds in the measurement area (area in the neck around the carotid artery).

Primary outcomes:
measure: Robustness of placement and measurement algorithms.
timeFrame: During data acquisition, which is pre-surgery.
measure: Verify and improve the arterial blood flow model.
timeFrame: During data acquisition, which is pre-surgery.
measure: Orientation of ultrasound probe.
timeFrame: During data acquisition, which is pre-surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis Eindhoven
state: Noord-Brabant
Study officials:
affiliation: Catharina Ziekenhuis Eindhoven
name: Arthur Bouwman, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Philips Electronics Nederland B.V.
name: John van Rooij, MSc
role: STUDY_CHAIR
References: