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

NCT ID: NCT05710445

Last Updated: 2024-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-16

Study Completion Date

2024-03-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Phlebotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Augmented Reality

Intervention Type OTHER

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Augmented Reality

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

Intervention Type OTHER

Other Intervention Names

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Microsoft HoloLens

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years
* Referral for US assisted placement

Exclusion Criteria

\- Urgent/emergent requirement for IV
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Ali Dhanaliwala

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ali H Dhanaliwala, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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852551

Identifier Type: -

Identifier Source: org_study_id

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