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
|Condition or disease||Intervention/treatment||Phase|
|Clinical Procedures Which Require Vessel Cannulations in Pediatric Patients||Device: SCENERGY||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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.|
|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|
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.
Use of the SCENERGY guidance device in conjunction with ultrasound to guide needles for pediatric vessel cannulations
- 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
- 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.
- 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.
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
|Contact: Dorothee Heisenberg, PhDemail@example.com|
|Contact: Kevin Cleary, PhD||202-476-3809||KCleary@childrensnational.org|