Multi-Day Evaluation of the TIVA Device

Velano Vascular

Status: Completed

Conditions: Blood Collections Via Peripheral IV Catheter

Treatments: Device: TIVA blood collection device

Study type: Interventional

Funder types: Industry

Identifiers

NCT02747147

CP-004

Details and patient eligibility

About

Prospective, randomized, single-center study to evaluate the ability of the device to collect good quality blood samples from patients with peripheral IV access over the length of their stay.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient will be admitted to the BWH unit 15 for post-surgical care
• Patient is at least 18 years old
• Patient is willing and physically / cognitively able to sign a written consent form
• Patient is willing and able to complete study questionnaires
• Patient is NOT a prisoner

Exclusion criteria

• Active hemodialysis
• Hemolytic disorders (e.g., sickle cell disease)
• Pregnancy

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

A- Control

No Intervention group

Description:

Group A will have their PIVs assessed daily and record kept of PIV dislodgement or replacement

B - Device Intervention

Experimental group

Description:

patients will have their PIVs assessed daily and record kept of PIV displodgement or replacement. patients will additionally have a single blood collection attempted using the study device

Treatment:

Device: TIVA blood collection device