Computer Assisted Instrument Guidance (CAIG) For Arterial Line Placement
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|ClinicalTrials.gov Identifier: NCT02584673|
Recruitment Status : Completed
First Posted : October 22, 2015
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Arterial and Midline Catheterization||Device: Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Computer Assisted Instrument Guidance (CAIG) For Arterial Line Placement|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||December 9, 2016|
|Actual Study Completion Date :||December 9, 2016|
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 Name: Clear Guide ONE
No Intervention: Control
The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
- Time Needed to Correctly Insert the Arterial or Midline Catheter. [ Time Frame: Immediately following intervention (within 2 hours) ]
- 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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02584673
|United States, New Jersey|
|The Cooper Health System|
|Camden, New Jersey, United States, 08103|
|Principal Investigator:||Irwin Gratz, DO||The Cooper Health System|