A Study Evaluating the Clinical Performance of the ViaValve™ Safety IV Catheter

N/ACompletedNCT02119351

Smiths Medical, ASD, Inc.150 enrolled

Overview

The objective of this post-market, prospective study is to evaluate the clinical acceptability, blood leakage, risk for blood exposure, need for digital compression, insertion success, and clinical utility of the ViaValve™ Safety IV Catheter compared to standard hospital PIVCs currently being used.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

150

Conditions

Peripheral Intravenous Catheter

Interventions

ViaValve™ Safety IV CatheterDEVICE

Safety peripheral IV catheter with a blood control feature

ProtectIV® Plus Safety IV CatheterDEVICE

Safety peripheral IV catheter with no blood control feature

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * A peripheral intravenous catheter will need to be inserted in order to gain access to a vein or artery to sample blood, monitor blood pressure, or administer fluids intravenous infusion as part of treatment. * Willing and able to sign an Informed Consent (patient or legally authorized representative). Exclusion Criteria: * Body morphology (e.g., size) precludes the use of a peripheral intravenous catheter. * Fluid to be infused is not appropriate for peripheral intravenous catheters.

Locations (1)

Foothills Medical Centre

Calgary, Alberta, Canada

Outcomes

Primary Outcomes

Clinical acceptability of PIVC insertion

Demonstrate non-inferiority of the ViaValve™ Safety I.V. Catheter compared to the control PIVC for ratings of clinical acceptability. Clinicians will agree or disagree that the device was clinically acceptable for the insertion.

Time frame: Clinicians will provide the rating immediately after performing the insertion

Frequency of blood leakage

Demonstrate superiority of the ViaValve™ Safety I.V. Catheter compared to the control in preventing blood leakage from the catheter hub during insertion.

Time frame: Clinicians will report if blood leakage occurred immediately after the catheter insertion

Eliminating risk of blood exposure

Demonstrate superiority of the ViaValve™ Safety I.V. Catheter compared to the control PIVC in eliminating the clinician's risk of blood exposure during the insertion process.

Time frame: Clinicians will report on the ability of the PIVC to eliminate blood exposure immediately after catheter insertion

Secondary Outcomes

Insertion success

Demonstrate the insertion success rate of the ViaValve™ I.V. Catheter is non-inferior to the control PIVC. Insertion success defined as a catheter confirmed successfully placed within the selected vessel in 3 or fewer venipuncture attempts.

Time frame: Clinicians will report if the insertion was successful immediately after performing insertion

Elimination of digital compression

Demonstrate that the ViaValve™ Safety I.V. Catheter is non-inferior to the control PIVC in eliminating the clinician's need to use digital compression during the insertion process. Clinicians will agree or disagree the device eliminates the need for digital compression after each PIVC insertion.

Time frame: Clinicians will provide the rating immediately after performing the insertion

Data from ClinicalTrials.gov

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