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

March 12, 2024 updated by: Ali Dhanaliwala, University of Pennsylvania
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

After being informed about the study, patients who require image guided intravenous access and give consent will have their intravenous catheter placed by a physician wearing mixed reality smart glasses. The mixed reality smart glasses will have an application that allows the physician to view the ultrasound images in a virtual monitor. The physician will then use the images viewed on this virtual monitor to guide placement of the intravenous catheter.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years
  • Referral for US assisted placement

Exclusion Criteria:

- Urgent/emergent requirement for IV

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Augmented Reality
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
Mixed reality smart glasses will be used to view a virtual monitor which mirrors the ultrasound screen in real-time.
Other Names:
  • Microsoft HoloLens
No Intervention: Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cannulation rate
Time Frame: At end of procedure, on average 30 minutes
Number of successful venous cannulations as evaluated by treating physician
At end of procedure, on average 30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cannulation attempts
Time Frame: At end of procedure, on average 30 minutes
Number of attempts needed to achieve a successful procedure
At end of procedure, on average 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Ali H Dhanaliwala, MD, PhD, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2023

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

January 9, 2023

First Submitted That Met QC Criteria

January 23, 2023

First Posted (Actual)

February 2, 2023

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 852551

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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