Computer Assisted Instrument Guidance (CAIG) For Arterial Line Placement

Not Applicable

Completed

• Conditions: Arterial and Midline Catheterization
• Interventions: Device: Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.

• Registration Number: NCT02584673
• Lead Sponsor: Clear Guide Medical

Brief Summary

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.

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 Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-21
• Study First Submitted QC: 2015-10-21
• Study First Posted: 2015-10-22
• Primary Completion: 2016-12-09
• Study Completion: 2016-12-09
• Results First Submitted: 2017-04-04
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-16
• Last Update Submitted: 2017-05-16
• Results First Posted: 2017-06-14
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Undergoing vessel catheterization
• Able to give written informed consent

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAIG	Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.	The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.

Primary Outcome Measures

Name	Time	Method
Time Needed to Correctly Insert the Arterial or Midline Catheter.	Immediately following intervention (within 2 hours)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Cooper Health System; 🇺🇸 Camden, New Jersey, United States