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Robustness Check of Placement and Measurement Algorithms for Blood Flow Measurement on Common Carotid Artery (RAdiUS)

Catharina Hospital logo

Catharina Hospital

Status

Completed

Conditions

Mitral Valve Disease
Coronary Artery Disease
Aortic Valve Disease

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT05193760
nWMO-2021.081 (Other Identifier)
ICBE 2-35542

Details and patient eligibility

About

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.

Full 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.

Enrollment

67 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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