Automatic Abdominal Aortic Aneurysm Diameter Measurement

Sponsor

Natasha Monzon Svendsen (Other)

Overall Status

Completed

CT.gov ID

NCT05983016

Collaborator

Philips Healthcare (Industry)

Enrollment

Location

Arms

Actual Duration (Days)

29.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Managing abdominal aortic aneurysms currently relies on diameter assessment with ultrasound. Diameter reproducibility with two-dimensional ultrasound is challenging, and requires experienced operators. A novel automatic three-dimensional ultrasound system has the potential to facilitate more precise diameter measurements than two-dimensional ultrasound. This study aimed to assess the variance of abdominal aortic aneurysm diameter measurements among ultrasound novices and experts by comparing two-dimensional ultrasound with the three-dimensional ultrasound system in a clinical setting.

Ten patients under abdominal aortic aneurysm surveillance were examined by 29 ultrasound-operators: 13 experts and 16 novices. The experts were sonographers and physicians highly experienced in abdominal aortic aneurysm ultrasound, and the novices were medical students and junior residents with sparse ultrasound experience.

Condition or Disease	Intervention/Treatment	Phase
AAA - Abdominal Aortic Aneurysm	Device: Philips EPIQ-7, Philips Healthcare, Bothell, WA, USA	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

The study had a semi blinded setup. The ultrasound operators were not able to see the results of the segmentation software.

Primary Purpose:

Diagnostic

Official Title:

Automated Three-dimensional Ultrasound Bridges the Gap Between Novices and Experts in Diameter Assessment of Abdominal Aortic Aneurysms

Actual Study Start Date :

Jan 15, 2022

Actual Primary Completion Date :

Feb 14, 2022

Actual Study Completion Date :

Feb 14, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Novices Novices measured abdominal aortic aneurysms in all patients using both two-dimensional and three-dimensional ultrasound	Device: Philips EPIQ-7, Philips Healthcare, Bothell, WA, USA All patients had their abdominal aortic aneurysm maximum anterior-posterior diameter estimated with two-dimensional ultrasound using a 5 MHz curved array transducer (Philips® C5-1 transducer, Philips Healthcare, Bothell, WA, USA). After the acquisition, a three-dimensional ultrasound acquisition was performed with a 3D-matrix transducer (Philips® X6-1 transducers, Philips Healthcare, Bothell, WA, USA).
Experimental: Experts Experts measured abdominal aortic aneurysms in all patients using both two-dimensional and three-dimensional ultrasound	Device: Philips EPIQ-7, Philips Healthcare, Bothell, WA, USA All patients had their abdominal aortic aneurysm maximum anterior-posterior diameter estimated with two-dimensional ultrasound using a 5 MHz curved array transducer (Philips® C5-1 transducer, Philips Healthcare, Bothell, WA, USA). After the acquisition, a three-dimensional ultrasound acquisition was performed with a 3D-matrix transducer (Philips® X6-1 transducers, Philips Healthcare, Bothell, WA, USA).

Arm

Intervention/Treatment

Experimental: Novices

Novices measured abdominal aortic aneurysms in all patients using both two-dimensional and three-dimensional ultrasound

Device: Philips EPIQ-7, Philips Healthcare, Bothell, WA, USA

All patients had their abdominal aortic aneurysm maximum anterior-posterior diameter estimated with two-dimensional ultrasound using a 5 MHz curved array transducer (Philips® C5-1 transducer, Philips Healthcare, Bothell, WA, USA). After the acquisition, a three-dimensional ultrasound acquisition was performed with a 3D-matrix transducer (Philips® X6-1 transducers, Philips Healthcare, Bothell, WA, USA).

Experimental: Experts

Experts measured abdominal aortic aneurysms in all patients using both two-dimensional and three-dimensional ultrasound

Device: Philips EPIQ-7, Philips Healthcare, Bothell, WA, USA

Outcome Measures

Primary Outcome Measures

Abdominal aortic aneurysm measurement variance between novices and experts [One week]
The primary outcome was to test the variance of abdominal aortic aneurysm diameter measurements by comparing expert and novice ultrasound operators using conventional 2D-ultrasound and 3D-software assisted ultrasound.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Physicians who had performed more than 200 abdominal aortic aneurysm examinations within the last two years preceding the study.
Medical students or junior residents who had performed less than 5 unsupervised abdominal aortic aneurysm ultrasound scans.
Patients with abdominal aortic aneurysm > 3 cm.