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NCT05204082 Clinical Trial

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

Intravenous Access Clinical Trial

Official title:
Use of SU-VEID™ As An Adjunct to Vein Visualization Technology to Improve Peripheral Venous Access Success in Children

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05204082
Other study ID # 21-006822
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date March 28, 2022
Est. completion date December 2023

Study information
Verified date April 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 400
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 18 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• 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.

Locations
Country Name City State
United States Mayo Clinic Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary IV Start first-attempt success rate Total number of participants to have an IV access within the first attempt when using the SU-VEID Device in comparison to the conventional procedure Baseline
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04875988 - Point of Care UltraSound (POCUS) Use for Intravenous Catheter Placement During Pediatric Interfacility Transport N/A
Completed NCT03029754 - Effect of Passive Leg Raise for Pediatric Peripheral IV Placement N/A
Completed NCT03299868 - Comparison Between Initial Routine PICC and General IV Access in Terminally Ill Cancer Patients Phase 2
Completed NCT04135547 - Venous Injection Compared To intraOsseous Injection During Resuscitation of Patients With Out-of-hospital Cardiac Arrest N/A
Completed NCT05695183 - IV SafeLock Device Functionality in Emergency Department N/A
Completed NCT02469038 - Ultrasound-Guided Peripheral Venous Access Using AccuCath N/A
Completed NCT04190407 - Intravenous Access Time in Pediatric Patients N/A

External Links