RIGHT IV Pilot Study

Smiths Medical

Status: Completed

Conditions: Peripheral Intravenous Catheters

Treatments: Device: Insyte Autoguard BC [Blood Control] Shielded IV Catheter; Device: ViaValve Safety IV Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT01792778

RIGHT IV Pilot Study

Details and patient eligibility

About

The purpose of this pilot study is to collect the necessary information for determining the appropriate sample size of a statistically powered trial comparing the performance of two different blood control peripheral intravenous catheters.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• Willing and able to independently sign an English Informed Consent
• Have adequate veins for placement of IV catheters in both right and left upper extremities

Exclusion criteria

• Currently taking anti-coagulation medication
• Have a known bloodborne disease or bleeding tendency
• Have a known fear or adverse reaction to needles or blood
• Women who are pregnant or nursing

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

ViaValve Safety IV Catheter

Active Comparator group

Description:

Catheter insertion using the ViaValve Safety IV Catheter.

Treatment:

Device: ViaValve Safety IV Catheter

Insyte Autoguard BC [Blood Control] Shielded IV Catheter

Active Comparator group

Description:

Catheter insertion using the Insyte Autoguard BC Shielded IV Catheter

Treatment:

Device: Insyte Autoguard BC [Blood Control] Shielded IV Catheter