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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether an augmented reality headset (Augmented Reality Heads-up Display) helps doctors better visualize ultrasound images when inserting an IV (a tube that goes into a vein) using an ultrasound machine. Participants are divided into two groups: one uses the traditional ultrasound monitor, and the other uses the headset. The trial aims to determine if the headset improves the ease and accuracy of IV placement. Suitable candidates are adults referred for an ultrasound-guided IV placement who do not require urgent care. As an unphased trial, this study offers a chance to contribute to innovative research that could enhance medical procedures.

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.

What prior data suggests that this augmented reality headset is safe for visualization during ultrasound guided procedures?

Research has shown that augmented reality (AR) systems can improve the accuracy of needle placements, crucial for procedures like inserting an IV catheter. One study demonstrated that using AR to guide needles resulted in a high success rate on the first attempt, with 77.4% of first attempts successful and fluid leakage into surrounding tissue occurring in only 17.7% of cases.

Another study found that AR reduced the time needed for procedures by 27% compared to traditional methods. Thus, AR not only enhances accuracy but also speeds up the process.

Overall, these findings suggest that AR headsets are generally safe and well-tolerated in medical settings. They improve accuracy and save time, with no major safety concerns reported for these procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using augmented reality (AR) for phlebotomy because it offers a futuristic way to improve how intravenous catheters are placed. Unlike the standard method, where physicians rely solely on ultrasound machine monitors, the AR approach uses a mixed reality headset to superimpose ultrasound images directly in the physician's field of vision. This innovative technique could make it easier to locate veins accurately, potentially reducing the time and discomfort associated with the procedure. The integration of AR technology aims to enhance precision and efficiency, making it a promising advancement in medical procedures.

What evidence suggests that this augmented reality headset is effective for ultrasound-guided catheter placement?

Research has shown that augmented reality (AR) helps healthcare providers place intravenous (IV) catheters more accurately. In this trial, one group of participants will have their IV catheters placed using standard care, while another group will use AR technology. Studies have found that AR technology makes ultrasound images easier to see, leading to more successful IV placements. Specifically, one study showed a 77.4% success rate on the first attempt at placing a catheter with AR tools. Additionally, AR reduces the mental effort needed for trainees, making procedures easier. Overall, AR increases confidence and skill in healthcare settings, making it a promising tool for improving IV insertion techniques. ^{2 4 6 7 8}

Who Is on the Research Team?

Ali H Dhanaliwala, MD, PhD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1876139924000161

The Effect of Augmented Reality Applications on ... This study was conducted to determine the effect of AR applications on the IV catheter placement skills, learning satisfaction and self-confidence levels of ...

2. withpower.com withpower.com/trial/phase-phlebotomy-1-2023-24077

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

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11429828/

Augmented reality visualization for ultrasound-guided ... AR technology helped improve trainee performance and reduced cognitive load during ultrasound-guided CVC placement.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12403271/

Application of head-mounted display-based augmented ... Therefore, this study aims to conduct a scoping review to explore the current applications of head-mounted display-based augmented reality and ...

5. bmcmededuc.biomedcentral.com bmcmededuc.biomedcentral.com/articles/10.1186/s12909-022-03946-y

Mixed reality simulation for peripheral intravenous catheter ... First attempt catheter placement was successful in 48 (77.4%) of cases. Only 11 (17.7%) and 3 (4.8) of participants caused 'extravasation' and ' ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12380000/

Evaluating Augmented Reality Head-Mounted Devices in ... This review systematically summarizes hardware, software, and usability assessment methods for AR HMDs in healthcare, analyzes current research ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11152052/

Virtual and Augmented Reality in Interventional Radiology A 27% reduction in total catheterization time, from 42.7 minutes to 31.0 minutes, was also observed with AR planning when compared prospectively. AR utilization ...

8. researchgate.net researchgate.net/publication/380254616_The_Effect_of_Augmented_Reality_Applications_on_Intravenous_Catheter_Placement_Skill_in_Nursing_Students_A_Randomized_Controlled_Study

The Effect of Augmented Reality Applications on ... The Effect of Augmented Reality Applications on Intravenous Catheter Placement Skill in Nursing Students: A Randomized Controlled Study ... To read the full-text ...