Computer Assisted Instrument Guidance (CAIG) For Arterial Line Placement
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 21, 2015
CompletedFirst Posted
Study publicly available on registry
October 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 9, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 9, 2016
CompletedResults Posted
Study results publicly available
June 14, 2017
CompletedJune 14, 2017
May 1, 2017
1.2 years
October 21, 2015
April 4, 2017
May 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Time Needed to Correctly Insert the Arterial or Midline Catheter.
Immediately following intervention (within 2 hours)
Secondary Outcomes (3)
Clinician Rating of the Device
Immediately following intervention (within 2 hours)
Number of Attempts
Immediately following intervention (within 2 hours)
Number of Times Needle Needs Repositioning
Immediately following intervention (within 2 hours)
Study Arms (2)
CAIG
EXPERIMENTALThe participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
Control
NO INTERVENTIONThe participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Undergoing vessel catheterization
- Able to give written informed consent
You may not qualify if:
- Unable to give informed consent
- Prisoners, pregnant women, and children
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Clear Guide Medicallead
- The Cooper Health Systemcollaborator
Study Sites (1)
The Cooper Health System
Camden, New Jersey, 08103, United States
Related Publications (1)
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.
PMID: 34637140DERIVED
Results Point of Contact
- Title
- Irwin Gratz
- Organization
- The Cooper Health System
Study Officials
- PRINCIPAL INVESTIGATOR
Irwin Gratz, DO
The Cooper Health System
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2015
First Posted
October 22, 2015
Study Start
October 1, 2015
Primary Completion
December 9, 2016
Study Completion
December 9, 2016
Last Updated
June 14, 2017
Results First Posted
June 14, 2017
Record last verified: 2017-05