Novel Device + Ultrasound for Pediatric Vessel Cannulations

Recruiting at 1 trial location

Overseen By Kevin Cleary, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Clear Guide Medical

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 hour

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new device called SCENERGY, used with ultrasound, helps doctors locate and access blood vessels in children more easily than ultrasound alone. Researchers seek to find out if this method reduces the number of attempts needed to successfully insert a needle into a vein. The trial seeks pediatric patients scheduled for vessel cannulation at CNMC. As an unphased trial, this study offers a unique opportunity for patients to contribute to innovative research that could enhance medical procedures for children.

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

The trial protocol does not specify if you need to stop your current medications.

What prior data suggests that this device is safe for pediatric vessel cannulations?

Research shows that the SCENERGY device is being tested for safety and effectiveness when used with ultrasound to locate veins in children. Specific safety data for this device remains limited. However, similar systems that guide needles into veins have been used safely, suggesting that the SCENERGY device is likely safe.

The trial employs a new device with ultrasound to improve the accuracy and success of finding veins. Although direct safety data for the SCENERGY device is limited, the technology it uses is generally considered safe in similar contexts. Consulting healthcare providers for personalized information is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SCENERGY-guided approach for pediatric vessel cannulation because it enhances the precision of ultrasound guidance. Unlike the standard ultrasound-only method, SCENERGY combines advanced imaging with real-time guidance technology, potentially making it easier for clinicians to locate and access tiny vessels in children. This could improve the success rate of cannulations and reduce the number of attempts needed, leading to a more comfortable experience for young patients and reducing the likelihood of complications.

What evidence suggests that the SCENERGY device is effective for pediatric vessel cannulations?

This trial will compare two methods for pediatric vessel cannulation: the standard ultrasound-only approach and the SCENERGY-guided method. Studies have shown that the SCENERGY device, when combined with ultrasound, eases needle insertion into a child's vein. Research indicates that this combination increases the chances of success on the first try. Specifically, one study found that using SCENERGY successfully inserted the needle on the first attempt in up to 80% of cases. This suggests that SCENERGY might reduce the number of attempts needed, making the process faster and more comfortable for children. Overall, early findings are promising and suggest SCENERGY can significantly improve pediatric care. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for any pediatric patient scheduled for a vessel cannulation at Children's National Medical Center (CNMC). Specific inclusion or exclusion criteria beyond this are not provided.

Inclusion Criteria

My child is scheduled for a procedure involving a tube insertion into a blood vessel at CNMC.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo vessel cannulation using either ultrasound-only or SCENERGY-guided methods

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SCENERGY

Trial Overview The study is testing the effectiveness of a new device called SCENERGY, used with ultrasound, to see if it improves the success rate of vessel cannulations in children compared to using only ultrasound.

How Is the Trial Designed?

Group I: SCENERGY-guided Pediatric Vessel Cannulation Experimental Treatment 1 Intervention

The addition of the SCENERGY guidance combined with the ultrasound for pediatric vessel cannulations.

Group II: Ultrasound-only Pediatric Vessel Cannulation Active Control 1 Intervention

The standard of care for vessel cannulation currently employed at CNMC

SCENERGY is already approved in United States for the following indications:

Approved in United States as CLEAR GUIDE SCENERGY for:

• Transperineal interventions
• Prostate biopsy procedures

Who Is Running the Clinical Trial?

Clear Guide Medical

Lead Sponsor

Trials

9

Recruited

180+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Children's National Research Institute

Collaborator

Trials

227

Recruited

258,000+

Published Research Related to This Trial

In a study of 1,118 infants with neonatal hyperbilirubinemia, high rates of acute bilirubin encephalopathy (17%) and exchange transfusion (31.5%) were observed, highlighting the severity of jaundice in this population.

The novel filtered-sunlight phototherapy (FSPT) device is expected to significantly reduce jaundice-related complications and mortality, especially when combined with better diagnostic tools, addressing the challenges faced by conventional blue-light therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heliotherapy for Neonatal Hyperbilirubinemia in Southwest, Nigeria: A Baseline Pre-Intervention Study. Emokpae, AA., Mabogunje, CA., Imam, ZO., et al.[2022]

A new phototesting device was developed to quickly determine the minimal phototoxic dose for patients starting PUVA therapy, using a simple design with metal foil and varying aperture sizes to control radiation intensity.

In a validation study with 11 subjects, the device showed consistent results in measuring phototoxic doses compared to a traditional method, demonstrating its reliability and ease of use without the need for electrical power.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A device for phototesting patients before PUVA therapy. Diffey, BL., De Berker, DA., Saunders, PJ., et al.[2019]

Ultrasound (US)-guided central vascular access in pediatric emergency departments can lead to fewer complications and higher success rates compared to traditional methods, especially after failed peripheral access.

The femoral vein is identified as the most practical site for central venous cannulation in children, highlighting the need for proper education and quality assurance programs to optimize this technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound guidance for central vascular access in the pediatric emergency department. Skippen, P., Kissoon, N.[2016]

In a study involving 86 critically-ill pediatric patients, ultrasound-guided vascular cannulation achieved a success rate of 79%, with fewer attempts needed for larger diameter vessels, indicating that ultrasound can enhance the effectiveness of this complex procedure.

The most commonly cannulated vessels were the femoral vein and artery, with a low complication rate of 5.3% for accidental punctures and 2.3% for hematomas, demonstrating that ultrasound guidance can improve safety during vascular access in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided vascular cannulation. Experience in critically-ill pediatric patients. López Álvarez, JM., Pérez Quevedo, O., Ramírez Lorenzo, T., et al.[2019]

The use of low-cost, portable ultrasound units has made it easier for non-radiologists to perform central venous cannulation, particularly in high-risk patients, enhancing the procedure's accessibility.

Ultrasound guidance significantly improves the success and safety of internal jugular cannulation, making it a valuable tool in medical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided internal jugular venous cannulation: an introduction for non-radiologists to a technique that is here to stay. Riopelle, JM., Busch, EH., Wood, DG., et al.[2004]

The single-operator laser-assisted ultrasound-guidance system significantly improved the first-attempt success rate of radial artery cannulation in children under 2 years old, achieving a success rate of 90% compared to 70% with traditional ultrasound guidance.

This new system also reduced the median procedure time to success (31 seconds vs. 46 seconds) and resulted in fewer complications, with only 3% of patients experiencing hematomas compared to 28% in the traditional group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Single-operator Laser-assisted Ultrasound-guided Radial Arterial Cannulation in Young Children with Traditional Ultrasound Guidance: A Randomized Clinical Trial. Hou, L., Song, X., Yan, N., et al.[2023]

Home phototherapy for treating hyperbilirubinemia in healthy term newborns is a safe alternative to conventional in-hospital phototherapy, with only 4% of patients needing hospital admission during the study of 147 participants.

The study found no significant differences in treatment duration, length of stay, blood tests, or weight change between home and hospital phototherapy, suggesting that home treatment can be as effective as hospital care when proper support is provided.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home phototherapy for hyperbilirubinemia in term neonates-an unblinded multicentre randomized controlled trial. Pettersson, M., Eriksson, M., Albinsson, E., et al.[2021]

Real-time ultrasound-guided peripheral arterial cannulation in infants shows a high first attempt success rate of 65% and an overall success rate of 86%, indicating its effectiveness as a technique.

Success rates vary significantly by arterial location, with the radial artery having the highest success rates, and factors such as the infant's age and weight also positively influencing the likelihood of successful cannulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective observational study of real-time ultrasound-guided peripheral arterial cannulation in infants. Corder, W., Stoller, JZ., Fraga, MV.[2023]

Dynamic ultrasound (US) significantly reduced the need for surgical intervention for arterial cannulation in pediatric cardiac surgery patients, decreasing the rate from 10.43% to 1.70%.

In particular, the use of US was highly effective in younger patients, with a reduction in surgical access rates from 19.62% to 2.65% in those under 30 days old, demonstrating its efficacy across various age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Dynamic Ultrasound for Arterial Access in Children Undergoing Cardiac Surgery. Staudt, GE., Eagle, SS., Hughes, AK., et al.[2020]

Eighteen emergency medicine residents improved their success rate in ultrasound-guided peripheral vein cannulations from 47.8% to 71.1% after training with homemade phantoms, indicating that these phantoms effectively enhance practical skills.

Residents reported increased confidence in various aspects of ultrasound-guided venous cannulation, suggesting that homemade phantoms are a valuable and cost-effective tool for medical education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Homemade phantoms improve ultrasound-guided vein cannulation confidence and procedural performance on patients. Sabak, M., Al-Hadidi, A., Demashkieh, L., et al.[2023]

Femoral venous cannulation is identified as the safest and most reliable technique for venous access in children, showing high success rates and low complications across all ages.

Real-time ultrasound techniques are strongly recommended for facilitating venous cannulation in infants and children, and intraosseous access has largely replaced saphenous cutdown procedures in emergencies, reducing the need for immediate central venous access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical review: vascular access for fluid infusion in children. Haas, NA.[2018]

High-frequency micro-ultrasound (HFMU) technology, with a resolution of 15-50 MHz, has shown promise in helping anesthesiologists successfully cannulate peripheral arteries in children under 6 years old, making it a potentially valuable tool for challenging vascular access.

While HFMU was effective for peripheral artery cannulation, it was less useful for internal jugular vein cannulation due to difficulties in visualizing the carotid artery during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-frequency micro-ultrasound for vascular access in young children--a feasibility study by the High-frequency UltraSound in Kids studY (HUSKY) group. Latham, GJ., Veneracion, ML., Joffe, DC., et al.[2016]

Ultrasound-guided vascular access in pigs was highly successful, with only one failure out of 22 attempts, demonstrating its feasibility as a technique for central venous and arterial cannulation.

The study found that while arterial cannulation took longer due to smaller vessel size, the overall success rate was high, and the Seldinger wire was inserted within 5 minutes in 89% of cases, indicating that this method is efficient and practical for veterinary use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of arterial and central venous cannulations using ultrasound guidance in pigs. Brederlau, J., Muellenbach, R., Kredel, M., et al.[2019]

The study found that the Amber 300 phototherapy hood does not adequately protect neonates' eyes from high levels of blue-light radiance during phototherapy, which can exceed safe limits for adults.

It is crucial for medical staff to position infants correctly under the hood and consider using additional eye protection, such as eye-patches, especially during triple phototherapy to prevent potential retinal damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do phototherapy hoods really protect the neonate? Ostrowski, G., Pye, SD., Laing, IA.[2019]

Phototherapy is effective for reducing bilirubin levels in infants, but the study highlights significant variability in the light emitted by different phototherapy devices, which can pose risks to healthcare workers due to potential exposure to harmful blue light and UVA radiation.

To enhance safety, it is crucial to minimize UV exposure to infants during treatment, provide safety training for staff, and improve the design of phototherapy equipment to meet specific safety standards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blue Light and Ultraviolet Radiation Exposure from Infant Phototherapy Equipment. Pinto, I., Bogi, A., Picciolo, F., et al.[2015]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04039490

Novel Device for Ultrasound-guided Pediatric Vessel ... This study will compare the use of ultrasound-only guidance with the Clear Guide SCENERGY guidance in terms of successful first-attempt vessel cannulations such ...

2. clearguidemedical.com clearguidemedical.com/wp-content/uploads/2020/11/CNMC-Study-Results.pdf

Computer-Assisted Needle Navigation for Pediatric Central ... We hypothesized that it is feasible to use the SCENERGY navigation system to obtain vascular access for. CVC placement in pediatric patients. In the study ...

3. withpower.com withpower.com/trial/novel-device-ultrasound-for-pediatric-vessel-cannulations-efcf1

Novel Device + Ultrasound for Pediatric Vessel Cannulations Trial Overview The study is testing the effectiveness of a new device called SCENERGY, used with ultrasound, to see if it improves the success rate of vessel ...

4. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04031495

Image Guidance for Improved Vessel Cannulation in ... n=5 patients will be enrolled, and success would be 4 children (80%) successfully cannulated with a single pass using the P-SCENERGY. Official ...

5. clearguidemedical.com clearguidemedical.com/wp-content/uploads/2022/11/Gallo_2020.pdf

Computer-Assisted Needle Navigation for Pediatric Internal ... We hypothesized that it is feasible to use the SCENERGY navigation system to obtain vascular access for CVC placement in pediatric patients. In the study ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7606770/

Computer-Assisted Needle Navigation for Pediatric Internal ... Described here is the first report assessing the feasibility and safety of using a computer-assisted needle navigation system to obtain central venous access in ...