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OpenTrials
Completed

NCT Number: NCT02584673

Computer Assisted Instrument Guidance (CAIG) For Arterial Line Placement

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.

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Key information

Conditions

Arterial and Midline Catheterization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Cooper Health System

Camden, New Jersey, 08103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Undergoing vessel catheterization
  • Able to give written informed consent

Exclusion criteria

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

Treatment and study plan

Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.

Device

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 names: Clear Guide ONE

Primary outcomes

  1. Time Needed to Correctly Insert the Arterial or Midline Catheter.

    Time frame: Immediately following intervention (within 2 hours)

Secondary outcomes

  1. Clinician Rating of the Device

    Time frame: Immediately following intervention (within 2 hours)

  2. Number of Attempts

    Time frame: Immediately following intervention (within 2 hours)

    Number of instrument pricks before target is reached

  3. Number of Times Needle Needs Repositioning

    Time frame: Immediately following intervention (within 2 hours)

Sponsors and collaborators

Lead sponsor

Clear Guide Medical

Industry

Collaborators

  • The Cooper Health System

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 22, 2015
Registry last updated
Jun 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.