Thermal Monitoring Device for Intravenous Complications

Overseen By Anna Somera

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Rhaeos, Inc.

Disqualifiers: Under 12, Serious skin reactions, others

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

Compensation: Varies

Number of Visits: 1

Duration: Up to 12 hours

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the NTISM device, which monitors skin temperature during outpatient infusion treatments. The goal is to determine if it can detect issues early, such as a malfunctioning IV (intravenous line). The device is intended for individuals scheduled for infusions lasting at least 30 minutes. Participants must have a clear skin area near the IV site for the device to adhere and should be available for a brief check after the infusion. Those with a history of serious skin reactions to certain adhesives may not be suitable for this trial. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could enhance infusion safety.

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. It seems focused on using a monitoring device during infusion treatments, so it's likely you can continue your medications, but you should confirm with the trial organizers.

What prior data suggests that this device is safe for use during infusion treatments?

Research has shown that the Non-invasive Thermal Infusion Site Monitor (NTISM) device helps track and prevent problems from IV (intravenous) therapy. IV therapy can sometimes cause issues like swelling, redness, or more serious problems such as tissue damage and infections, occurring in up to 70% of cases with traditional IVs.

The NTISM device monitors the temperature of the infusion site to catch problems early, potentially lowering the risk of serious complications. However, specific information on the safety of the NTISM device is not yet available. As this is an exploratory study, researchers are still determining its safety and effectiveness.

Prospective participants should weigh the potential benefits of early problem detection against the ongoing collection of safety data. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The NTISM device is unique because it offers continuous thermal monitoring to detect intravenous (IV) complications early. Current methods typically rely on periodic visual checks and patient-reported symptoms, which can miss subtle changes indicating problems. By providing real-time data, the NTISM device aims to catch issues like infiltration or phlebitis before they become severe, potentially improving patient outcomes significantly. Researchers are excited about this technology because it could lead to safer and more effective IV therapy, especially in pediatric and outpatient settings.

What evidence suggests that the NTISM device is effective for monitoring intravenous complications?

Research has shown that problems at IV sites, such as vein inflammation, fluid leaking into nearby tissue, and fluid leaking out of a vein, commonly affect over half of patients. These issues can cause discomfort and delay treatment. In this trial, the Non-invasive Thermal Infusion Site Monitor (NTISM) will monitor participants for early signs of these problems by detecting temperature changes at the IV site. Early detection might help prevent or lessen these issues. Although specific data on the NTISM's effectiveness is limited, the device aims to improve patient safety by identifying problems early. ^{3 6 7 8 9}

Who Is on the Research Team?

R. Chad Webb

Principal Investigator

Rhaeos, Inc.

Are You a Good Fit for This Trial?

This trial is for individuals scheduled to receive an outpatient infusion therapy lasting at least 30 minutes, with healthy skin near the catheter site and who can stay for monitoring after device removal. It's not for those under 12, with adverse reactions to silicone adhesives or Tegaderm, or where the device interferes with care.

Inclusion Criteria

I can stay an extra 15 minutes for monitoring after the study device is removed.

Signed informed consent

I am scheduled for an infusion therapy that lasts at least 30 minutes.

Exclusion Criteria

Use of the study device would interfere with standard patient care that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject

Investigator judges that the intravenous

I am younger than 12 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo outpatient infusion procedures while being monitored with the NTISM device

Up to 12 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 minutes

What Are the Treatments Tested in This Trial?

Interventions

• NTISM device

Trial Overview The study is testing a Non-invasive Thermal Infusion Site Monitor (NTISM) during routine outpatient infusions. The NTISM device aims to improve patient safety by detecting temperature changes that may indicate problems like infiltration or extravasation at the infusion site.

How Is the Trial Designed?

Group I: IV Infusion Patients Experimental Treatment 1 Intervention

Pediatric patients over the age of 12 and adult patients with planned outpatient infusion procedures scheduled will be enrolled in this study.

Who Is Running the Clinical Trial?

Rhaeos, Inc.

Lead Sponsor

Trials

11

Recruited

690+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10916754/

The Prevalence and Associated Factors of Peripheral ... 1 The use of peripheral intravenous catheters is associated with the risk of complications such as phlebitis, infiltration, and extravasation.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7928085/

Local complications of intravenous access – an often ... Our study shows that local complications at IV access site are very common with occurrence in more than fifty percent patients. Several risk ...

3. pdfs.semanticscholar.org pdfs.semanticscholar.org/cbaf/58344b7266baabc61e352aaefbaf5f270400.pdf

The Occurrence of Peripheral Intravenous Catheter ... Peripheral IV catheter failure rates and specific complication rates determined by prospective randomized controlled trials were compiled. Total annual ...

4. monashhealth.org monashhealth.org/wp-content/uploads/2019/06/CCE_IV_Teams_Infection_Insertion_Deskilling_2092018.pdf

IV night teams: Impact on Infection rates, insertion success ... Dr Carlos Scheinkestel, Executive Director, Quality, Safety and Patient Experience has requested CCE provide a review of the evidence on IV night teams.

5. bmcnurs.biomedcentral.com bmcnurs.biomedcentral.com/articles/10.1186/s12912-022-01164-x

Incidence, time to occurrence and predictors of peripheral ... Flushing of the cannula after securement decreases the risk of PIVC complications by 29% (AHR = 0.71, 95%CI: 0.34–0.98) as compared to ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK594499/table/ch1therapy.T.local_complications_of_peri/

Table 1.3a, [Local Complications of Peripheral IV Therapy[],[]]. Signs and symptoms include pain, swelling, redness, the skin surrounding the insertion site is cool to touch, there is a change in the quality or flow of IV, ...

7. nursingcenter.com nursingcenter.com/ncblog/february-2015-(1)/complications-of-peripheral-i-v-therapy

Complications of Peripheral I.V. Therapy | NursingCenter Extravasation can cause severe local tissue damage, possibly leading to delayed healing, infection, tissue necrosis, disfigurement, loss of function, and even ...

8. intechopen.com intechopen.com/chapters/65572

Dangers of Peripheral Intravenous Catheterization Finally, less frequent but significant complications have been reported, including bloodstream and local infections, air embolization, nerve damage, arterial ...

9. safetyandquality.gov.au safetyandquality.gov.au/publications-and-resources/resource-library/infections-associated-peripheral-venous-access-devices-rapid-review-literature

Infections associated with peripheral venous access devices Despite frequency in PIVC use, complications are reported to be as high as 70%. They can be prone to blockage and dislodgment, cause inflammation of the vein ...