ivWatch Sensor for Peripheral IV Infiltration
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new device called the ivWatch Model 400 with Milky Way Sensor. It monitors IV sites to detect fluid leaks into surrounding tissue, known as infiltration. The trial involves monitoring IV sites on the forearm and hand while introducing a saline solution. Ideal participants are healthy adults without conditions such as hemophilia, allergies to medical materials, or recent infections. As an unphased trial, participants contribute to innovative research that could enhance patient care and safety.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on a daily regimen of blood thinning medication.
What prior data suggests that the ivWatch Model 400 with Milky Way Sensor is safe for observing infiltrated tissues?
Research shows that the ivWatch Model 400, equipped with its Milky Way Sensor, monitors IV sites for potential leaks, which occur when fluid escapes into nearby tissue. Studies indicate that this device uses visible and near-infrared light to track changes in the tissue where the IV is placed, aiding in early problem detection.
Tests have been conducted in scenarios where leaks are known to occur, such as when a small amount of saline (a saltwater solution) is intentionally injected into the tissue. These tests demonstrated that the device functions effectively without causing harm. The ivWatch Model 400 has received approval for use in both adults and children to detect leaks during IV therapy, suggesting it is generally safe.12345Why are researchers excited about this trial?
Researchers are excited about the ivWatch Model 400 with the Milky Way Sensor because it offers a new way to monitor IV infiltrations in real-time. Unlike traditional methods that rely on visual inspections and patient complaints, this innovative sensor can detect infiltration early by continuously measuring changes in the tissue. This proactive monitoring could significantly reduce complications and improve patient outcomes by allowing for timely intervention.
What evidence suggests that the ivWatch Model 400 with Milky Way Sensor is effective for detecting peripheral IV infiltration?
Research shows that the ivWatch Model 400 with the Milky Way Sensor effectively spots IV (intravenous) problems early. In a small study, the device identified issues 80% of the time before nurses did. This capability allows it to warn healthcare workers about problems faster, potentially preventing complications. In this trial, the ivWatch Milky Way sensors will monitor IV sites during the infiltration of isotonic saline solution. The device continuously monitors IV sites and sends alerts if something seems off. These results suggest the sensor can enhance patient care by catching problems early.678910
Are You a Good Fit for This Trial?
This trial is for adults over 18 who are healthy as confirmed by a Health History Form. It's designed to test the ivWatch Model 400 with Milky Way Sensor on people receiving peripheral IV therapy.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ivWatch sensors to monitor IV sites during infiltration of isotonic saline solution
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ivWatch Model 400 with Milky Way Sensor
Trial Overview
The study is testing the safety and effectiveness of the ivWatch Model 400 equipped with the Milky Way Sensor in detecting tissue infiltration at common IV sites, using a single group of adult volunteers.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
The ivWatch Milky Way sensors monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.
Find a Clinic Near You
Who Is Running the Clinical Trial?
ivWatch, LLC
Lead Sponsor
Citations
Milky Way Sensor: Device Validation for Infiltrated Tissues
The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr. Intervention/Treatment, Device : ivWatch Model 400 with Milky Way Sensor.
Optical Detection of Intravenous Infiltration: A Pilot Study
The ivWatch Model 400 is intended as an aid to clinicians for continuous monitoring and early detection of infiltrations. In the non-alarming group, the median ...
JAVA Study: Evaluating ivWatch Technology in Pediatric IV ...
The key finding of the pilot study was the device detected a peripheral IV infiltration 80 percent of the time before the clinician detected the ...
Study Details | NCT07228416 | Milky Way Sensor Motion ...
The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period. Intervention/Treatment, Device : ivWatch Model ...
Evaluation of optical sensor technology for the early detection ...
Once detected, the ivWatch monitor alerts healthcare providers to a potential infiltration and prompts them to check the infusion site.
MODEL 400
The ivWatch® Model 400 provides continuous monitoring of peripheral IVs to aid in the detection of conditions that may indicate an intravenous (IV) infiltration ...
December 22, 2016 ivWatch, LLC Jaclyn Lautz Director of ...
The ivWatch Model 400 uses visible and near-infrared light to measure changes in the optical properties of the tissue near a PIV insertion site.
User Manual
The ivWatch Model 400 is intended to aid in the detection of infiltrations and extravasations during peripheral IV infusion therapy in pediatric and adult ...
ivWatch Sensor: Device Validation for Infiltrated Tissues
The ivWatch Model 400 sensors monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the ...
Fiber Optic Sensor - White Paper
The Early Stage Detection of Peripheral IV Infiltrations study demonstrated the effectiveness of the ivWatch Model 400 in scenarios where it was known that an ...
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