Augmented Reality Heads-up Display to Improve Ultrasound Guided IV Access

NCT05710445 | Withdrawn

• 1 other identifier: 852551
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the utility of an augmented reality headset for visualization of ultrasound images during ultrasound guided placement of an intravenous catheter.

Conditions

Phlebotomy

Keywords

Catheters; Augmented Reality; Ultrasound

Outcome Measures

Primary Outcomes (1)

• Cannulation rate

  Number of successful venous cannulations as evaluated by treating physician

  At end of procedure, on average 30 minutes

Secondary Outcomes (1)

• Cannulation attempts

  At end of procedure, on average 30 minutes

Study Arms (2)

Augmented Reality

EXPERIMENTAL

Subjects in this group will have their intravenous catheter placed while the physician uses a mixed reality headset to view the ultrasound images being used to guide the catheter placement.

Other: Augmented Reality

Control

NO INTERVENTION

Subjects in this group will have their intravenous catheter placed using standard of care. The physician will use the monitor on the ultrasound machine only to view the ultrasound images being used to guide the catheter placement.

Interventions

Augmented Reality OTHER

Mixed reality smart glasses will be used to view a virtual monitor which mirrors the ultrasound screen in real-time.

Also known as: Microsoft HoloLens

Augmented Reality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Referral for US assisted placement

You may not qualify if:

• \- Urgent/emergent requirement for IV

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

• Ali H Dhanaliwala, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: Subjects will be randomly assigned to one of two groups. In the first group intravenous catheters will be placed per standard of care. In the second group, the catheter will be placed while the physicians utilizes augmented reality.

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: February 2, 2023
• Study Start: February 16, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)