Computer Assisted Instrument Guidance (CAIG) For Arterial Line Placement

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 Overview

• Status: Completed
• Conditions: Arterial and Midline Catheterization
• Intervention / Treatment: Device: Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • The Cooper Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Undergoing vessel catheterization
• Able to give written informed consent

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAIG; The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.	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.; Other Names: Clear Guide ONE
No Intervention: Control; The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Clear Guide Medical
• Collaborators: The Cooper Health System
• Investigators: Principal Investigator: Irwin Gratz, DO, The Cooper Health System

Publications and helpful links

General Publications

• Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): December 9, 2016
• Study Completion (Actual): December 9, 2016

Study Registration Dates

• First Submitted: October 21, 2015
• First Submitted That Met QC Criteria: October 21, 2015
• First Posted (Estimate): October 22, 2015

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: May 16, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CGM 15-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes