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Clinical Trials/NCT02584673
NCT02584673
Completed
Not Applicable

Computer Assisted Instrument Guidance (CAIG) For Arterial Line Placement

Clear Guide Medical1 site in 1 country30 target enrollmentOctober 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arterial and Midline Catheterization
Sponsor
Clear Guide Medical
Enrollment
30
Locations
1
Primary Endpoint
Time Needed to Correctly Insert the Arterial or Midline Catheter.
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
December 9, 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Clear Guide Medical
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Undergoing vessel catheterization
  • Able to give written informed consent

Exclusion Criteria

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

Outcomes

Primary Outcomes

Time Needed to Correctly Insert the Arterial or Midline Catheter.

Time Frame: Immediately following intervention (within 2 hours)

Secondary Outcomes

  • Number of Attempts(Immediately following intervention (within 2 hours))
  • Clinician Rating of the Device(Immediately following intervention (within 2 hours))
  • Number of Times Needle Needs Repositioning(Immediately following intervention (within 2 hours))

Study Sites (1)

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