Multi-Day Evaluation of the TIVA Device

NCT ID: NCT02747147

Last Updated: 2017-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-12

Study Completion Date

2016-12-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Blood Collections Via Peripheral IV Catheter

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A- Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

B - Device Intervention

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

Group Type EXPERIMENTAL

TIVA blood collection device

Intervention Type DEVICE

the device is attached to a peripheral IV catheter for use as a direct blood draw device into a vacuum tube or a syringe

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TIVA blood collection device

the device is attached to a peripheral IV catheter for use as a direct blood draw device into a vacuum tube or a syringe

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Velano Vascular, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Deborah F Mulloy, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CP-004

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Capillary-Venous Paired Collection
NCT06183151 NOT_YET_RECRUITING
Accuracy Verification of the INVOS PM7100
NCT07166341 ACTIVE_NOT_RECRUITING
LAVA TQ Doppler Functionality Study
NCT05504733 COMPLETED NA