HoloUS: Augmented Reality Ultrasound Guidance

Sponsor
Children's National Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05964439
Collaborator
(none)
44
1
1
21.7
2

Study Details

Study Description

Brief Summary

Many medical procedures are done with the aid of ultrasound imaging, but they remain difficult to learn and perform. This study will use augmented reality technology for making these procedures potentially more intuitive, easier, more precise, and safer.

Condition or Disease Intervention/Treatment Phase
  • Device: HoloUS app for ultrasound visualization
N/A

Detailed Description

Minimally invasive ultrasound-guided procedures are a mainstay of modern medicine and the number of such procedures continues to grow. Safe, efficient, and precise execution of these procedures requires a clear visualization of the target anatomy and the interventional device (e.g., a needle). While sustained advances in ultrasound technology have led to greatly enhanced visualization of the anatomy and the needle with high image quality, hand-eye coordination of the practitioner continues to be a challenge. In order to properly position the interventional device, the practitioner must alternate their attention between observing the patient, advancing the needle, and viewing the ultrasound image on a separate screen. This study's long-term goal is to develop an advanced visualization platform for ultrasound-guided procedures to overcome this challenge by greatly simplifying hand-eye coordination. The proposed platform will be developed using the latest advances in the augmented reality (AR) technology. Through wearable, see-through AR glasses, the platform will create a virtual display placed in the practitioner's field of view to show live ultrasound images, registered with the transducer and the patient, in the form of a hologram. The investigative team hypothesizes that such visualization will reduce the time of procedure by 20%. This study is aimed providing the practitioner a more intuitive and efficient platform to perform ultrasound-guided procedures and demonstrating improved efficiency through user studies.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
HoloUS: Augmented Reality Visualization of Live Ultrasound Images Using HoloLens for Ultrasound-guided Procedures
Actual Study Start Date :
Mar 11, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: HoloUS app for ultrasound visualization

This is a single-arm study. Each study participant will evaluate HoloUS app and serve as their own control.

Device: HoloUS app for ultrasound visualization
Study participants will wear HoloLens see-through glasses and use the HoloUS app for ultrasound visualization in the conduct of a vascular access procedure in a phantom.

Outcome Measures

Primary Outcome Measures

  1. Task completion time [The total time from when the needle first punctured the surface of the phantom to when fluid was successfully aspirated into the syringe, or 10 minutes, whichever occurred first]

    This outcome measure examines if the use of augmented reality leads to faster procedure.

Secondary Outcome Measures

  1. Number of attempts [From when the needle first punctured the surface of the phantom to when fluid was successfully aspirated into the syringe, or 10 minutes, whichever occurred first.]

    Number of times the user needed to successfully withdraw fluid from the vessel.

  2. Number of head adjustments [From when the needle first punctured the surface of the phantom to when fluid was successfully aspirated into the syringe, or 10 minutes, whichever occurred first.]

    Number of times the user moved or turned their head from its baseline position at the start of the procedure until task completion.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Employees of the institution over 18 years.

  • Volunteers participants who provide oral consent.

  • For expert group, participants who have been trained to perform and are comfortable with point-of-care ultrasound procedures (e.g., residents, fellows, attendings, vascular access PAs/NPs).

Exclusion Criteria:
  • Any previous experience or training using the current version of the HoloUS app on the HoloLens.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's National Hospital Washington District of Columbia United States 20010

Sponsors and Collaborators

  • Children's National Research Institute

Investigators

  • Principal Investigator: Raj Shekhar, PhD, Children's National Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Children's National Research Institute
ClinicalTrials.gov Identifier:
NCT05964439
Other Study ID Numbers:
  • Pro00016558
First Posted:
Jul 28, 2023
Last Update Posted:
Jul 28, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No

Study Results

No Results Posted as of Jul 28, 2023