Computer Assisted Instrument Guidance (CAIG) For Arterial Line Placement

Study Overview
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Brief Summary
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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
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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.

Official Title
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Computer Assisted Instrument Guidance (CAIG) For Arterial Line Placement

Conditions
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Arterial and Midline Catheterization

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing vessel catheterization Able to give written informed consent Exclusion Criteria: Unable to give informed consent Prisoners, pregnant women, and children

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAIG<br>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.<br>* 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.<br>* Other names: Clear Guide ONE;|
| No Intervention: Control<br>The participants in the control group will receive the procedure with traditional ultrasound methods and equipment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |
| --- | --- | --- |
| Clinician Rating of the Device |  | Immediately following intervention (within 2 hours) | 
| 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) |