Arterial and Midline Catheterization
Conditions
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.
Interventions
DEVICEComputer 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.
Sponsors
The Cooper Health System
Clear Guide Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing vessel catheterization * Able to give written informed consent
Exclusion criteria
* Unable to give informed consent * Prisoners, pregnant women, and children
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time Needed to Correctly Insert the Arterial or Midline Catheter. | Immediately following intervention (within 2 hours) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Rating of the Device | Immediately following intervention (within 2 hours) | — |
| Number of Attempts | Immediately following intervention (within 2 hours) | Number of instrument pricks before target is reached |
| Number of Times Needle Needs Repositioning | Immediately following intervention (within 2 hours) | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CAIG The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
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. | 15 |
| Control The participants in the control group will receive the procedure with traditional ultrasound methods and equipment. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Total | CAIG | Control |
|---|---|---|---|
| Age, Customized | 0 Participants | — | — |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment United States | 30 Participants | 15 Participants | 15 Participants |
| Sex/Gender, Customized | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Time Needed to Correctly Insert the Arterial or Midline Catheter.
Time frame: Immediately following intervention (within 2 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAIG | Time Needed to Correctly Insert the Arterial or Midline Catheter. | 30.07 Seconds | Standard Deviation 28.63 |
| Control | Time Needed to Correctly Insert the Arterial or Midline Catheter. | 44.76 Seconds | Standard Deviation 33.96 |
Secondary
Clinician Rating of the Device
Time frame: Immediately following intervention (within 2 hours)
Population: This data was not collected
Secondary
Number of Attempts
Number of instrument pricks before target is reached
Time frame: Immediately following intervention (within 2 hours)
Population: This data was not collected
Secondary
Number of Times Needle Needs Repositioning
Time frame: Immediately following intervention (within 2 hours)
Population: This data was not collected