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

Study Overview
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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.

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

Conditions
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Phlebotomy

Intervention / Treatment
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* Other: Augmented Reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Referral for US assisted placement Exclusion Criteria: - Urgent/emergent requirement for IV

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Augmented Reality<br>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<br>* Mixed reality smart glasses will be used to view a virtual monitor which mirrors the ultrasound screen in real-time.<br>* Other names: Microsoft HoloLens;|
| No Intervention: Control<br>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?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Catheters, Augmented Reality, Ultrasound