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Novel Device for Ultrasound-guided Pediatric Vessel Cannulations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04039490
Recruitment Status : Not yet recruiting
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Children's National Research Institute
Information provided by (Responsible Party):
Clear Guide Medical

Brief Summary:
Clinical Trial to investigate whether the use of a novel device to be used in conjunction with ultrasound in pediatric vessel cannulations is superior to ultrasound-only pediatric vessel cannulations in terms of number of cannulation attempts.

Condition or disease Intervention/treatment Phase
Clinical Procedures Which Require Vessel Cannulations in Pediatric Patients Device: SCENERGY Not Applicable

Detailed Description:
Use of needle guidance plus ultrasound imaging for CVC placement in the pediatric high-risk population may facilitate the procedure with a single needle pass and decrease the incidence of adverse effects by minimizing additional needle passes. 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 as internal jugular and fermoral artery access. The question is whether it is possible to make ultrasound-guided pediatric vascular access less technically challenging in order to improve adoption and utilization leading to decreased iatrogenic complications and improved patient safety.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: two-arm study, comparing ultrasound-only pediatric vessel cannulations versus SCENERGY-guided pediatric vessel cannulations
Masking: None (Open Label)
Masking Description: Because the SCENERGY is an attachment to the ultrasound probe, it cannot be masked.
Primary Purpose: Other
Official Title: Novel Device for Ultrasound-guided Pediatric Vessel Cannulations
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
No Intervention: Ultrasound-only Pediatric Vessel Cannulation
The standard of care for vessel cannulation currently employed at CNMC
Experimental: SCENERGY-guided Pediatric Vessel Cannulation
The addition of the SCENERGY guidance combined with the ultrasound for pediatric vessel cannulations.
Device: SCENERGY
Use of the SCENERGY guidance device in conjunction with ultrasound to guide needles for pediatric vessel cannulations




Primary Outcome Measures :
  1. Successful first-attempt vessel cannulation [ Time Frame: 1 hour ]
    Test if the vessel cannulation was successful with only 1 attempt --needle puncture--to reach the vessel


Secondary Outcome Measures :
  1. Non-IR Personnel Successfully Cannulate Pediatric Patients [ Time Frame: 1 hour ]
    Test if non-specialists can learn to successfully cannulate pediatric patients with only 1 needle puncture.

  2. Point-of-Care Successful Cannulation [ Time Frame: 1 hour ]
    Test whether the SCENERGY makes possible successful pediatric vessel cannulations at patient's point of care location.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Month to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • any pediatric patient scheduled for a vessel cannulation at CNMC

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039490


Contacts
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Contact: Dorothee Heisenberg, PhD 4435703835 heisenberg@clearguidemedical.com
Contact: Kevin Cleary, PhD 202-476-3809 KCleary@childrensnational.org

Sponsors and Collaborators
Clear Guide Medical
National Institutes of Health (NIH)
Children's National Research Institute
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Responsible Party: Clear Guide Medical
ClinicalTrials.gov Identifier: NCT04039490    
Other Study ID Numbers: CNMC Ph II Trial
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Pediatric Postmarket Surveillance of a Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Clear Guide Medical:
pediatrics
vessel cannulations
ultrasound-guided