Augmented Reality Assistance for Phlebotomy

Overseen By Ali H Dhanaliwala, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Urgent IV requirement

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

Trial Summary

What is the purpose of this trial?

This trial uses special glasses that show ultrasound images to help doctors place IV catheters more accurately in patients who need precise IV access.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is augmented reality for needle guidance safe for humans?

The research primarily focuses on the accuracy and feasibility of augmented reality systems for needle guidance, but it does not provide specific safety data for humans. ^{1 2 3 4 5}

How does the Augmented Reality Heads-up Display treatment for phlebotomy differ from other treatments?

The Augmented Reality Heads-up Display for phlebotomy is unique because it uses advanced technology to help guide the healthcare provider during the procedure, potentially improving accuracy and reducing discomfort. Unlike traditional methods, this treatment involves visual aids that enhance the provider's ability to locate veins, which is not typically available in standard phlebotomy practices. ^{1 6 7 8 9}

What data supports the effectiveness of the treatment Augmented Reality Heads-up Display for phlebotomy?

Research shows that augmented reality (AR) systems can improve the accuracy of needle placements, as seen in studies using AR for needle guidance and venous puncture. These findings suggest that AR could help make phlebotomy (drawing blood) more accurate and successful. ^{1 3 4 6 10}

Research Team

Ali H Dhanaliwala, MD, PhD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for adults (18+) who need help placing an IV with ultrasound guidance. It's not suitable for those needing urgent or emergency IV placement.

Inclusion Criteria

Referral for US assisted placement

Exclusion Criteria

I need urgent IV treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants undergo ultrasound guided intravenous catheter placement using either standard care or augmented reality headset

1 day

1 visit (in-person)

Follow-up

Participants are monitored for immediate outcomes such as cannulation attempts and success rate

1 day

Treatment Details

Interventions

• Augmented Reality Heads-up Display

Trial Overview The study tests if using an augmented reality headset to see ultrasound images helps in guiding the insertion of an intravenous catheter more effectively.

Participant Groups

Group I: Augmented Reality Experimental Treatment 1 Intervention

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 II: Control Active Control 1 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.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Findings from Research

The study evaluated a 3D augmented reality protractor for needle placement accuracy, finding no significant difference in placement errors between two methods (Fix-On-Screen and QR-Tracking), with average errors of 5.6 mm and 6.1 mm respectively.

The Fix-On-Screen method was faster, taking an average of 71 seconds compared to 98 seconds for the QR-Tracking method, making it a more convenient option for clinical use as it does not require additional markers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Out-of-Plane Needle Placements Using 3D Augmented Reality Protractor on Smartphone: An Experimental Phantom Study. Morita, S., Suzuki, K., Yamamoto, T., et al.[2023]

The augmented reality (AR) system combined with a 1.5-T closed-bore MRI for needle biopsies demonstrated high accuracy, with a mean localization error of just 1.1 mm for virtual targets and successful punctures in all animal trials.

The average procedure time for AR-guided biopsies was 18 minutes, indicating that this method is not only feasible but also efficient for performing biopsies in a clinical setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An augmented reality system for MR image-guided needle biopsy: initial results in a swine model. Wacker, FK., Vogt, S., Khamene, A., et al.[2007]

A new laboratory validation system has been developed to accurately measure operator performance in needle placement procedures, which is crucial for improving augmented reality (AR) systems used in medical imaging.

Preliminary studies using this system have begun to compare different assistance techniques, such as AR guidance and traditional methods, to assess their accuracy and effectiveness in guiding needle placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation system of MR image overlay and other needle insertion techniques. Fischer, GS., Dyer, E., Csoma, C., et al.[2007]

A user study comparing three augmented reality (AR) navigation concepts for needle insertion tasks revealed a clear ranking in effectiveness, indicating that AR can significantly enhance instrument navigation in medical procedures.

Logarithmic scaling of navigation indicators improved accuracy in needle insertion tasks, although participants found it more challenging than linear scaling, highlighting the need for balancing accuracy and user-friendliness in AR navigation designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Projective Augmented Reality Concepts to Support Medical Needle Insertion. Heinrich, F., Joeres, F., Lawonn, K., et al.[2020]

An augmented reality guidance system for MRI-guided needle placement was developed and tested, showing a targeting error of only 1.09 mm and an overall error of 2.29 mm during procedures, indicating high accuracy.

The system allows physicians to focus on the insertion site without needing special headgear or secondary monitors, enhancing usability and efficiency in MRI suites during procedures like biopsies and arthrography.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In situ guidance for MRI interventions using projected feedback. Foroughi, P., Demir, A., Hossbach, M., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Out-of-Plane Needle Placements Using 3D Augmented Reality Protractor on Smartphone: An Experimental Phantom Study. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Effects of a new device to guide venous puncture in elderly critically ill patients: results of a pilot randomized study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Smartphone Augmented Reality CT-Based Platform for Needle Insertion Guidance: A Phantom Study. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Smartphone- versus smartglasses-based augmented reality (AR) for percutaneous needle interventions: system accuracy and feasibility study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

An augmented reality system for MR image-guided needle biopsy: initial results in a swine model. [2007]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Validation system of MR image overlay and other needle insertion techniques. [2007]

7. United States pubmed.ncbi.nlm.nih.gov

Comparison of Projective Augmented Reality Concepts to Support Medical Needle Insertion. [2020]

8. Germany pubmed.ncbi.nlm.nih.gov

In situ guidance for MRI interventions using projected feedback. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

Augmented virtuality for arthroscopic knee surgery. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Stereo imagery from the UNC augmented reality system for breast biopsy guidance. [2004]