Augmented Reality Tool for PICC Placement

Overseen By Ali H Dhanaliwala, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Emergent catheter placement, under 18

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an augmented reality tool that helps doctors place peripherally inserted central catheters (PICC). The tool, called the augmented reality virtual ruler, uses virtual measurements to assist in catheter placement, aiming to enhance accuracy and efficiency. Individuals scheduled for a non-emergency PICC placement in Interventional Radiology might be suitable candidates. The trial focuses on improving the precision of this common medical procedure. As an unphased trial, participants can contribute to pioneering advancements in medical technology.

Do I need to stop my current medications for this trial?

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

What prior data suggests that this augmented reality virtual ruler is safe for PICC placement?

Studies have shown that augmented reality tools can assist in medical procedures. The augmented reality virtual ruler, currently tested for catheter placement, is one such tool. This ruler enables doctors to measure distances accurately using special glasses.

Research indicates that tools like this virtual ruler can enhance procedural performance. However, limited information exists about potential side effects or problems associated with its use. As a new measurement aid, it may not pose direct risks to patients.

The augmented reality virtual ruler is not a medicine or treatment in the traditional sense. It functions as a special tool for doctors, differing from a new drug trial. Available evidence does not indicate harm to patients. Overall, it appears safe, but further studies could provide clearer insights. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the augmented reality virtual ruler for PICC placement because it offers a cutting-edge way to improve accuracy in medical procedures. Unlike traditional methods that often rely on manual measurements and estimation, this tool uses augmented reality to provide precise measurements for catheter length during placement. This innovation could reduce the risk of complications and improve patient outcomes by ensuring more exact catheter placement. Additionally, it streamlines the procedure for physicians, potentially making it quicker and more efficient.

What evidence suggests that this augmented reality tool is effective for PICC placement?

Research has shown that an augmented reality virtual ruler can help doctors place medical tubes, such as peripherally inserted central catheters (PICC), with greater accuracy. In this trial, physicians will use the augmented reality virtual ruler to measure catheter length during placement. Tests demonstrated that this virtual ruler precisely measures distances, which is crucial for correct catheter placement. The tool employs special glasses, enabling doctors to see and measure the exact placement of the catheter. Other studies have found that augmented reality tools enhance the accuracy of procedures requiring precise measurements. Overall, these findings suggest that the augmented reality virtual ruler could make catheter placement safer and more accurate. ^{1 2 3 5 6}

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 over 18 who are scheduled to have a non-emergency peripherally inserted central catheter (PICC) placed in Interventional Radiology. It's not for anyone under 18 or those needing an emergency PICC placement.

Inclusion Criteria

I am scheduled for a planned PICC line placement.

I am over 18 years old.

Exclusion Criteria

I am under 18 years old.

I am getting a special IV line placed in my arm soon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Procedure

Placement of peripherally inserted central catheters using augmented reality virtual ruler

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after catheter placement

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Augmented reality virtual ruler

Trial Overview The study is testing the use of an augmented reality virtual ruler to see if it can improve safety and clinical workflow during the placement of PICCs, which are used for long-term medication administration.

How Is the Trial Designed?

Group I: Augmented reality virtual ruler Experimental Treatment 1 Intervention

Patient's in this arm will have their physician use an augmented reality virtual ruler to measure catheter length during catheter placement.

Augmented reality virtual ruler is already approved in United States, European Union for the following indications:

Approved in United States as Augmented Reality Virtual Ruler for:

• PICC placement assistance
• Clinical measurement aid

Approved in European Union as Mixed Reality Ruler for:

• Medical measurement assistance
• Sterile field maintenance aid

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

The use of augmented reality software significantly reduced the mean tip apex distance (TAD) in lag screw placement for hip fracture repairs, with a TAD of 10.7 mm in the AR group compared to 15.4 mm in the control group, indicating improved accuracy.

The augmented reality software also enhanced the success rate of achieving optimal screw positioning, with 50.9% of cases reaching the center position on the AP view and 68.4% on the lateral view, compared to only 7.0% and 12.3% in the control group, respectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Cephalad Lag Screw Placement in the Femoral Head During Cephalomedullary Nailing Using a Novel Augmented Reality System. Konda, SR., Solasz, S., Derken, M., et al.[2023]

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]

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]

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 pilot study involving 40 medical students and anesthesiology residents showed that augmented reality (AR) technology significantly enhances the training experience for needle insertion in central venous catheter placement, with 92.5% of participants finding the internal anatomy projection helpful.

While both experienced and inexperienced trainees were able to place the needle correctly, less experienced participants had a higher risk of inadvertently puncturing the carotid artery, highlighting the need for further development and evaluation of AR in medical training to improve safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-Person Point-of-View-Augmented Reality for Central Line Insertion Training: A Usability and Feasibility Study. Rochlen, LR., Levine, R., Tait, AR.[2022]

An augmented reality solution was developed to assist surgeons in distal locking during intramedullary nailing procedures, significantly reducing the need for X-ray guidance and associated radiation exposure.

In a preclinical study with four clinicians, the augmented reality system achieved a 100% success rate for positioning the intramedullary nail and a 93% success rate for distal locking, demonstrating its efficacy and safety in a timely manner.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-operative augmented reality in distal locking. Londei, R., Esposito, M., Diotte, B., et al.[2018]

Using augmented reality (AR) glasses for central line simulation is feasible and shows promise as an educational tool for novice operators, with 32 participants in the study.

While the AR group did not significantly reduce the time for internal jugular cannulation compared to conventional methods, they demonstrated a higher level of adherence to the procedure, suggesting potential benefits in training effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of augmented reality glasses in central line simulation: "see one, simulate many, do one competently, and teach everyone". Huang, CY., Thomas, JB., Alismail, A., et al.[2022]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05399875?intr=Virtual%20Reality&rank=7

Study Details | NCT05399875 | AR Ruler to Improve Safety ... The purpose of this study is to assess the utility of an augmented reality virtual ruler during placement of peripherally inserted central catheters.

2. withpower.com withpower.com/trial/phase-insertion-of-peripherally-inserted-central-catheter-5-2022-e5dff

Augmented Reality Tool for PICC Placement This trial tests special glasses with a virtual ruler to help doctors place medical tubes accurately in patients who need precise catheter placement. Show more.

3. spiedigitallibrary.org spiedigitallibrary.org/conference-proceedings-of-spie/11931/2612406/An-augmented-reality-measurement-tool-for-clinical-procedures/10.1117/12.2612406.full

An augmented reality measurement tool for clinical ... The custom app calculates the linear distance between the user's fingers. The accuracy of the virtual ruler was tested under various conditions ...

4. researchgate.net researchgate.net/publication/368844078_Validation_of_the_effectiveness_of_augmented_reality-assisted_vascular_puncture_An_experimental_model

Validation of the effectiveness of augmented reality ... Purpose To demonstrate that the augmented reality-assisted puncture technique improves the efficacy of ultrasound-guided puncture to get central ...

5. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05399875?keyword=%22Radiology%22

AR Ruler to Improve Safety and Clinical Workflow During PICC ... The mixed reality smart glasses will have an application that allows the physician to measure distances with their hands. This application will be used to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11607048/

Evaluation of augmented reality training for a navigation ... This study compares the potential of an augmented reality (AR) training application with conventional instructions for the Cube Navigation System (CNS).