Trial Outcomes & Findings for Computer Assisted Instrument Guidance (CAIG) For Arterial Line Placement (NCT NCT02584673)
NCT ID: NCT02584673
Last Updated: 2017-06-14
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Immediately following intervention (within 2 hours)
Results posted on
2017-06-14
Participant Flow
Participant milestones
| Measure |
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.
|
Control
The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This data was not collected
Baseline characteristics by cohort
| Measure |
CAIG
n=15 Participants
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.
|
Control
n=15 Participants
The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
—
|
—
|
0 Participants
This data was not collected
|
|
Sex/Gender, Customized
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
30 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Immediately following intervention (within 2 hours)Outcome measures
| Measure |
CAIG
n=15 Participants
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.
|
Control
n=15 Participants
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.
|
30.07 Seconds
Standard Deviation 28.63
|
44.76 Seconds
Standard Deviation 33.96
|
SECONDARY outcome
Timeframe: Immediately following intervention (within 2 hours)Population: This data was not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Immediately following intervention (within 2 hours)Population: This data was not collected
Number of instrument pricks before target is reached
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Immediately following intervention (within 2 hours)Population: This data was not collected
Outcome measures
Outcome data not reported
Adverse Events
CAIG
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place