Computer Assisted Instrument Guidance (CAIG) For Arterial Line Placement

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 9, 2016

Detailed 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.

Interventions

  • Device: Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.
    • The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure.

Arms, Groups and Cohorts

  • Experimental: CAIG
    • The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
  • No Intervention: Control
    • The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.

Clinical Trial Outcome Measures

Primary Measures

  • Time Needed to Correctly Insert the Arterial or Midline Catheter.
    • Time Frame: Immediately following intervention (within 2 hours)

Secondary Measures

  • Clinician Rating of the Device
    • Time Frame: Immediately following intervention (within 2 hours)
  • Number of Attempts
    • Time Frame: Immediately following intervention (within 2 hours)
    • Number of instrument pricks before target is reached
  • Number of Times Needle Needs Repositioning
    • Time Frame: Immediately following intervention (within 2 hours)

Participating in This Clinical Trial

Inclusion Criteria

  • Undergoing vessel catheterization – Able to give written informed consent Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Clear Guide Medical
  • Collaborator
    • The Cooper Health System
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Irwin Gratz, DO, Principal Investigator, The Cooper Health System

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