Augmented Reality Tool for PICC Placement

Overseen By Ali H Dhanaliwala, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Pennsylvania

Disqualifiers: Emergent catheter placement, under 18

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests special glasses with a virtual ruler to help doctors place medical tubes accurately in patients who need precise catheter placement.

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 data supports the effectiveness of the augmented reality tool for PICC placement?

Research shows that augmented reality (AR) tools can improve accuracy in medical procedures, such as needle placements and central line insertions, by providing better visualization and navigation. Studies have demonstrated that AR can enhance the precision of needle insertion angles and depths, suggesting that similar AR tools could be effective for PICC placement. ^{1 2 3 4 5}

Is the augmented reality tool for PICC placement safe for humans?

The research articles do not provide specific safety data for the augmented reality tool for PICC placement, but they do explore the usability and feasibility of similar AR systems for medical procedures, suggesting that these tools are generally considered safe for training and improving accuracy in needle-based interventions. ^{2 3 4 5 6}

How is the augmented reality tool for PICC placement different from other treatments?

The augmented reality tool for PICC placement is unique because it uses a virtual ruler to help guide the placement of the catheter, providing real-time visual feedback to improve accuracy. This approach is different from traditional methods that rely solely on manual techniques and imaging, as it enhances precision and potentially reduces the difficulty of the procedure. ^{3 4 5 7 8}

Research Team

Ali H Dhanaliwala, MD, PhD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Augmented reality virtual ruler (Other)

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.

Participant Groups

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.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Findings from Research

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 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]

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 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 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]

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 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]

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. New Zealand 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". [2022]

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

First-Person Point-of-View-Augmented Reality for Central Line Insertion Training: A Usability and Feasibility Study. [2022]

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

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

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

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

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

Improving Cephalad Lag Screw Placement in the Femoral Head During Cephalomedullary Nailing Using a Novel Augmented Reality System. [2023]

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

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

7. Germany pubmed.ncbi.nlm.nih.gov

Intra-operative augmented reality in distal locking. [2018]

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

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