Trial Outcomes & Findings for Computer Assisted Instrument Guidance (CAIG) for Orthopedic Peripheral Nerve Blocks (NCT NCT02614222)
NCT ID: NCT02614222
Last Updated: 2017-07-07
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
Immediately after intervention (within 2 hours)
Results posted on
2017-07-07
Participant Flow
Participant milestones
| Measure |
Peripheral Nerve Block With CAIG
The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
Peripheral Nerve Blocks with CAIG: 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.
|
Peripheral Nerve Block Without CAIG
The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
14
|
|
Overall Study
COMPLETED
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Computer Assisted Instrument Guidance (CAIG) for Orthopedic Peripheral Nerve Blocks
Baseline characteristics by cohort
| Measure |
Peripheral Nerve Block With CAIG
n=13 Participants
The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
Peripheral Nerve Blocks with CAIG: 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.
|
Peripheral Nerve Block Without CAIG
n=14 Participants
The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=99 Participants
|
14 participants
n=107 Participants
|
27 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Immediately after intervention (within 2 hours)Outcome measures
| Measure |
Peripheral Nerve Block With CAIG
n=13 Participants
The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
Peripheral Nerve Blocks with CAIG: 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.
|
Peripheral Nerve Block Without CAIG
n=14 Participants
The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
|
|---|---|---|
|
Time Needed to Correctly Identify the Neural Structure(s) and Induce the Peripheral Nerve Block
|
2.606944444 Minutes
Standard Deviation 1.445017966
|
2.179761905 Minutes
Standard Deviation 0.510579467
|
SECONDARY outcome
Timeframe: Immediately following intervention (within 2 hours)Population: Data for this outcome measure was not collected
Clinician rates the device on a scale of 1-10. This also includes a questionnaire.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Immediately following intervention (within 2 hours)Population: This data was not collected for 3 (out of 27) participants.
Number of instrument pricks before target is reached
Outcome measures
| Measure |
Peripheral Nerve Block With CAIG
n=12 Participants
The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
Peripheral Nerve Blocks with CAIG: 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.
|
Peripheral Nerve Block Without CAIG
n=12 Participants
The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
|
|---|---|---|
|
Number of Attempts
|
1 Attempts
Standard Deviation 0
|
1 Attempts
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Immediately following intervention (within 2 hours)Population: Data for this outcome measure was not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Post-op day 1Population: This data was not collected for 5 (out of 27) participants.
Patient satisfaction will be recorded in the hospital or via phone on post-op day 1, on a 10-point scale (10 being most satisfied), using a questionnaire.
Outcome measures
| Measure |
Peripheral Nerve Block With CAIG
n=10 Participants
The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
Peripheral Nerve Blocks with CAIG: 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.
|
Peripheral Nerve Block Without CAIG
n=12 Participants
The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
|
|---|---|---|
|
Patient Satisfaction Recorded on Post-op Day 1 Using Questionnaire
|
8.727272727 Units on a Scale
Standard Deviation 1.489356176
|
9.181818182 Units on a Scale
Standard Deviation 1.662418829
|
SECONDARY outcome
Timeframe: During hospital stay (maximum 3 days)Population: This data was not collected for 4 (out of 27) patients
Outcome measures
| Measure |
Peripheral Nerve Block With CAIG
n=12 Participants
The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
Peripheral Nerve Blocks with CAIG: 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.
|
Peripheral Nerve Block Without CAIG
n=11 Participants
The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
|
|---|---|---|
|
Number of Patients That Needed Rescue Opioids
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: During hospital stay (maximum 3 days)Population: This data was not collected for 4 (out of 27) participants.
Number of participants that reported postoperative nausea and vomiting
Outcome measures
| Measure |
Peripheral Nerve Block With CAIG
n=11 Participants
The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
Peripheral Nerve Blocks with CAIG: 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.
|
Peripheral Nerve Block Without CAIG
n=12 Participants
The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
|
|---|---|---|
|
Incidence of Postoperative Nausea and Vomiting
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: During hospital stay (maximum 3 days)Population: This data was not collected for 6 (out of 27) participants.
Number of participants that report undesired muscle weakness. Undesired muscle weakness will be measured subjectively - whether patient unable to ambulate and/or requiring the use of an immobilizer.
Outcome measures
| Measure |
Peripheral Nerve Block With CAIG
n=11 Participants
The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
Peripheral Nerve Blocks with CAIG: 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.
|
Peripheral Nerve Block Without CAIG
n=10 Participants
The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
|
|---|---|---|
|
Undesired Muscle Weakness Measured Subjectively
|
2 Participants
|
1 Participants
|
Adverse Events
Peripheral Nerve Block With CAIG
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Peripheral Nerve Block Without CAIG
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