Clinical trial NCT05964439: Augmented Reality Ultrasound Guidance
Official title: HoloUS: Augmented Reality Visualization of Live Ultrasound Images Using HoloLens for Ultrasound-guided Procedures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Paracentesis
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Task completion time
timeFrame: 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
Secondary outcomes:
measure: Number of attempts
timeFrame: 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.
measure: Number of head adjustments
timeFrame: 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.
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Hospital
state: District of Columbia
Study officials:
affiliation: Children's National Research Institute
name: Raj Shekhar, PhD
role: PRINCIPAL_INVESTIGATOR
References: