Computer Assisted Instrument Guidance (CAIG) For Arterial Line Placement

Clear Guide Medical

Status: Completed

Conditions: Arterial and Midline Catheterization

Treatments: Device: Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02584673

CGM 15-001

Details and patient eligibility

About

The objective of this research is to verify the procedural improvements enabled by use of a CAIG system to supplement existing ultrasound guided, needle-based procedures. The primary focus will be procedures performed by the Anesthesia department.

Full description

The study will utilize two groups of patients: control and test. The control group will receive the procedure with traditional methods and equipment currently in use at Cooper University. The test group will receive the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system. It is anticipated that 100 patients will be included in the study. After each procedure completion times, number of needle repositions, and punctures will be recorded along with an "ease of procedure" self-reported qualitative metric from the physician performing the procedure.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Undergoing vessel catheterization
• Able to give written informed consent

Exclusion criteria

• Unable to give informed consent
• Prisoners, pregnant women, and children

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

CAIG

Experimental group

Description:

The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.

Treatment:

Device: Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.

Control

No Intervention group

Description:

The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.