Novel Device for Ultrasound-guided Pediatric Vessel Cannulations

NCT ID: NCT04039490

Last Updated: 2024-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-06

Study Completion Date

2025-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Clinical Procedures Which Require Vessel Cannulations in Pediatric Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two-arm study, comparing ultrasound-only pediatric vessel cannulations versus SCENERGY-guided pediatric vessel cannulations
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Because the SCENERGY is an attachment to the ultrasound probe, it cannot be masked.

Study Groups

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Ultrasound-only Pediatric Vessel Cannulation

The standard of care for vessel cannulation currently employed at CNMC

Group Type NO_INTERVENTION

No interventions assigned to this group

SCENERGY-guided Pediatric Vessel Cannulation

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

Group Type EXPERIMENTAL

SCENERGY

Intervention Type DEVICE

Use of the SCENERGY guidance device in conjunction with ultrasound to guide needles for pediatric vessel cannulations

Interventions

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SCENERGY

Use of the SCENERGY guidance device in conjunction with ultrasound to guide needles for pediatric vessel cannulations

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* any pediatric patient scheduled for a vessel cannulation at CNMC

Exclusion Criteria

* none
Minimum Eligible Age

1 Month

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Children's National Research Institute

OTHER

Sponsor Role collaborator

Clear Guide Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Children's National Medical Center

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Dorothee Heisenberg, PhD

Role: CONTACT

4435703835

Kevin Cleary, PhD

Role: CONTACT

202-476-3809

Facility Contacts

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Karun Sharma, MD

Role: primary

301-565-8447

Other Identifiers

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CNMC Ph II Trial

Identifier Type: -

Identifier Source: org_study_id

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