A Study to Evaluate SU-VEID™ for Improving Peripheral Venous Access Success in Children

NCT ID: NCT05204082

Last Updated: 2024-05-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

169 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-28

Study Completion Date

2022-07-21

Brief Summary

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The purpose of this study is to determine if use of the SU-VEID™ in children facilitates an increase success rate of peripheral intravenous starts, in comparison to the conventional method of vein entry techniques.

Detailed Description

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Conditions

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Intravenous Access

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standard IV Insertion

Pediatric patients in surgical pre-op requiring an IV catheter for surgery will have standard IV insertion

Group Type NO_INTERVENTION

No interventions assigned to this group

SU-VEID assisted IV Insertion

Pediatric patients in surgical pre-op requiring an IV catheter for surgery will have IV insertion using SU-VEID device

Group Type OTHER

Single Use Vein Entry Indicator Device

Intervention Type DEVICE

Electronic pressure sensing device, integrated to a conventional needle catheter, and which indicates continuously during intravenous cannulation whether the tip of the needle is inside or outside of a vein, to assist a clinician in intravenous cannulation.

Interventions

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Single Use Vein Entry Indicator Device

Electronic pressure sensing device, integrated to a conventional needle catheter, and which indicates continuously during intravenous cannulation whether the tip of the needle is inside or outside of a vein, to assist a clinician in intravenous cannulation.

Intervention Type DEVICE

Other Intervention Names

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SU-VEID

Eligibility Criteria

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Inclusion Criteria

* Patient age \< 18 years old.
* Pediatric patients in surgical pre-op (0-18 years old), requiring an I.V. catheter for surgery who are difficult venous access.
* Written informed consent/ assent from the patient or legal guardian.

Exclusion Criteria

\- Patient age \> 18 years old.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Michael E. Nemergut

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Nemergut, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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21-006822

Identifier Type: -

Identifier Source: org_study_id

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