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Completed

NCT Number: NCT02119351

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

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.

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Key information

Conditions

Peripheral Intravenous Catheter

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foothills Medical Centre

Calgary, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ViaValve™ Safety IV Catheter

Device

Safety peripheral IV catheter with a blood control feature

ProtectIV® Plus Safety IV Catheter

Device

Safety peripheral IV catheter with no blood control feature

Primary outcomes

  1. Clinical acceptability of PIVC insertion

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

  2. Frequency of blood leakage

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

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

  3. Eliminating risk of blood exposure

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

    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.

Secondary outcomes

  1. Insertion success

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

    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.

  2. Elimination of digital compression

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

    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.

  3. Ease of Use

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

    Demonstrate that the ViaValve™ Safety I.V. Catheter is non-inferior to the control PIVC in seven measures of ease of use. Clinicians will agree or disagree with seven statements regarding ease of use/clinical utility.

Sponsors and collaborators

Lead sponsor

Smiths Medical, ASD, Inc.

Industry

Registry information

Official study title

A Post-market, Randomized Study Evaluating the Clinical Performance of the ViaValve™ Safety IV Catheter

Acronym: ViaValve-001

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 21, 2014
Registry last updated
Apr 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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