What side effects are associated with this type of intervention?

Common treatments for phlebotomy, such as the use of intravenous catheters, can have side effects including pain at the insertion site, bruising, infection, and in rare cases, damage to surrounding tissues or nerves. The use of augmented reality headsets for enhanced visualization during ultrasound-guided IV placement aims to reduce these risks by improving accuracy and reducing the number of attempts needed for successful catheter placement.

What prior FDA approvals exist?

The provided context does not mention any specific FDA-approved treatments for phlebotomy or related drugs. Additionally, there is no direct reference to the use of augmented reality or enhanced visualization technologies in the context of phlebotomy. Generally, phlebotomy is a procedure that involves drawing blood from a patient, and while advanced technologies like augmented reality headsets are being studied to improve visualization during procedures such as intravenous catheter placement, there are no specific FDA approvals mentioned for phlebotomy treatments using these technologies.

What other types of research exist?

Promising alternatives to augmented reality headsets for enhanced visualization of ultrasound images in phlebotomy include: 1) Advanced ultrasound devices with improved image resolution and portable designs, 2) Vein visualization devices using near-infrared (NIR) technology to highlight veins, 3) Artificial intelligence (AI)-assisted ultrasound systems that provide real-time guidance and feedback, and 4) Robotic-assisted IV insertion systems that combine imaging and precision mechanics to improve success rates.

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Augmented Reality Assistance for Phlebotomy

N/A

Waitlist Available

Led By Ali H Dhanaliwala, MD, PhD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at end of procedure, on average 30 minutes

Awards & highlights

No Placebo-Only Group

Summary

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

Who is the study for?

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.

What is being tested?

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

What are the potential side effects?

Since this trial involves a non-invasive technology, there may be minimal side effects related to discomfort from wearing the headset or distraction during the procedure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at end of procedure, on average 30 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at end of procedure, on average 30 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and at end of procedure, on average 30 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cannulation rate

Secondary study objectives

Cannulation attempts

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Augmented RealityExperimental Treatment1 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: ControlActive Control1 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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Phlebotomy, commonly used to treat conditions like polycythemia vera, involves the removal of blood to decrease red blood cell mass and reduce blood viscosity. This helps prevent complications such as thrombosis. The use of augmented reality headsets for enhanced visualization of ultrasound images can significantly improve the accuracy and efficiency of intravenous catheter placement during phlebotomy. This technology allows healthcare providers to better visualize veins, reducing the risk of complications and improving patient outcomes.

Effectiveness of caregiver-mediated exercise interventions on activities of daily living, anxiety and depression post-stroke rehabilitation: A systematic review and meta-analysis.Phlebotonics for venous insufficiency.Lessons Learned From a Randomized Controlled Trial of Short-Course Intravenous Antibiotic Therapy for Erysipelas and Cellulitis of the Lower Limb (Switch Trial).