Telerobotic Ultrasound for Carotid Imaging - Feasibility Study

Stroke Clinical Trial

Official title:

Telerobotic Ultrasound for Carotid Imaging - Feasibility Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05654935
• Other study ID #: 13090301-IRB01
• Status: Withdrawn
• Start date: March 26, 2014
• Est. completion date: March 25, 2016

Study information

• Verified date: January 2023
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this proposal, the investigators will demonstrate the feasibility and noninferiority of telerobotic ultrasonography as compared to traditional manual acquisition in performing a limited carotid Duplex examination and in carotid plaque detection.

Description:

BACKGROUND Ultrasonography is an inexpensive, noninvasive, radiation-free diagnostic tool that is indispensable in modern medicine. Carotid intima-media thickness (IMT) and carotid atherosclerotic plaque detection have been powerful screening tools for identifying patients at risk for cardiovascular events; including myocardial infarction, cardiac death, and stroke. The need for trained sonographers by the patient side to perform quality ultrasound studies has limited the accessibility to this imaging tool, both in terms of location and time of day. Robotic arms controlled remotely over the internet, by trained sonographers, can potentially provide easier and more ubiquitous access to ultrasonography in and outside traditional medical facilities, including remote villages in underdeveloped countries, disaster areas, battle zones, etc. In this proposal, the investigators will demonstrate the feasibility and noninferiority of telerobotic ultrasonography as compared to traditional manual acquisition in performing a limited carotid Duplex examination and in carotid plaque detection. HYPOTHESIS: Telerobotic ultrasound performed by an experienced sonographer over the Internet produces diagnostic images with quality similar to manual conventional imaging. AIMS: 1. Telerobotic ultrasonography produces diagnostic images of the carotid arteries at a rate that is non-inferior to those obtained using standard manual acquisition. 2. Telerobotic ultrasonography can detect carotid atherosclerotic plaques at a rate that is non-inferior to the gold standard of manual acquisition. IMPLICATIONS: Realizing our study aims could mark a new era in ultrasonography. There are wide applications for telerobotic carotid ultrasonography in atherosclerosis screening. Furthermore, establishing the noninferiority of telerobotic carotid ultrasonography acquisition will provide a rationale for further studies in telerobotic ultrasonography, including echocardiography. This in turn has even wider clinical applications such as emergency studies in hospitals during weekends and after-hours. In addition, this could pave the way for use in disaster areas and battle zones where expert sonographers may not be available on-site.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 25, 2016
• Est. primary completion date: March 25, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for Cohort A

• Healthy volunteer
• >18 years of age
• Signed informed consent

Exclusion criteria for Cohort A include:

• Prior stroke or transient ischemic attack
• Prior heart attack.
• Prior angioplasty/stent of the heart artries
• Prior bypass surgery of the heart
• Known history of peripheral arterial disease claudication Peripheral arterial revascularization
• known history of carotid artery stenosis

Exclusion criteria for Cohort B include:

• known history of carotid artery stenosis
• known history carotid artery dissection

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Arteriosclerosis
• Atheromatous Plaques
• Atherosclerosis
• Cardiac Death
• Cardiovascular Disease
• Cardiovascular Diseases
• Carotid Artery Disease
• Carotid Artery Diseases
• Cerebral Infarction
• Cerebrovascular Accident
• Cerebrovascular Disorders
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Coronary Disease
• Death
• Heart Diseases
• Infarction
• Myocardial Infarction
• Myocardial Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Plaque, Atherosclerotic
• Stroke
• Vascular Disease
• Vascular Diseases

Intervention

Radiation:
• Ultrasound for Carotid Arteries
Cohort A: each subject will undergo two manual ultrasound image acquisitions by two different registered vascular sonographers who will be blinded to one another's images and findings. Cohort B: each subject in Cohort B will undergo one manual ultrasound acquisition conducted at Rush University Medical Center.
• Telerobotic Ultrasound for Carotid Arteries
Cohort A: each subject will undergo two separate telerobotic acquisitions, in which the robotic arm will be controlled by two separate sonographers from Mount Sinai Medical Center (New York, NY). The sonographers controlling the robotic arm will be blinded to one another's images and to the images from the manual acquisition. Cohort B: each subject will undergo one telerobotic ultrasound (in random sequence with the manual acquisition also performed for this cohort) acquired by a separate technologist than the technologist that acquired the subject's manual ultrasound. This acquisition will be conducted at Rush University Medical Center by a technologist blinded to the images of the manual acquisition technologist. Robotic acquisition will be manipulated from a different building at Rush University Medical Center using a broadband cellular internet signal (rather than the institutional intranet).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	Icahn School of Medicine at Mount Sinai

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Quality of Telerobotic Ultrasound.	Gray scale examination of the right and left carotid arteries in 3 views: short axis view of the common carotid artery, long axis view of carotid bifurcation, and short axis view post bifurcation. Images will be analyzed for: Diagnostic image quality (diagnostic vs. non-diagnostic quality) by 2 reviewers blinded to image acquisition modality (manual vs. telerobotic).; Image quality graded on a scale from 1 to 4 by the same two reviewers as 1) poor/non-diagnostic; 2) fair; 3) acceptable; 4) good/excellent.; Evaluation for diagnostic quality will be performed by two independent observers who will be blinded to the modality of image acquisition. Disagreement between observers will be resolved by a third blinded observer.	3 months
Secondary	Carotid Intima-Media Thickness (CIMT) Measurement	The subjects will be evaluated for the presence or absence of carotid artery atherosclerotic plaques. Each carotid artery (left and right) will be treated as an independent subject. Agreement analysis in the diagnosis of carotid artery plaques, between manual and telerobotic acquisition, will be performed. Identification of carotid artery plaques will be performed by two independent observers. Disagreements will be resolved by a third blinded observer.	3 months
Secondary	Subject Experience with Manual vs. Telerobotic Ultrasound	Subject experience with each imaging technique (manual vs. telerobotic) will be determined by a simple questionnaire, as follows: How did the subject feel during the examination? Comfortable; fairly comfortable; somewhat uncomfortable; very uncomfortable.; Would the subject have this test again in the future? Definitely, probably; probably not, definitely not.	3 months