Trial Outcomes & Findings for Safety and Effectiveness of a Computer-Assisted Personalized Sedation (CAPS) Device for Propofol Delivery During Endoscopy (NCT NCT00452426)
NCT ID: NCT00452426
Last Updated: 2011-01-25
Results Overview
AUCDesat measures desaturation as a function of incidence, magnitude, and duration. AUCDesat is the difference between the threshold and actual oxygen saturation measured every second. The total area below the 90% threshold is summated to determine AUCDesat in units of seconds\*percent.
COMPLETED
PHASE3
1000 participants
From administration of initial drug dose until subject recovered from effects of sedation
2011-01-25
Participant Flow
Participant milestones
| Measure |
Sedation System
Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
|
Current Standard of Care
Site's current standard used for delivery of sedation
|
|---|---|---|
|
Overall Study
STARTED
|
496
|
504
|
|
Overall Study
COMPLETED
|
489
|
493
|
|
Overall Study
NOT COMPLETED
|
7
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Effectiveness of a Computer-Assisted Personalized Sedation (CAPS) Device for Propofol Delivery During Endoscopy
Baseline characteristics by cohort
| Measure |
Sedation System
n=496 Participants
Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
|
Current Standard of Care
n=504 Participants
Site's current standard used for delivery of sedation
|
Total
n=1000 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
53 years
STANDARD_DEVIATION 13 • n=99 Participants
|
53 years
STANDARD_DEVIATION 14 • n=107 Participants
|
53 years
STANDARD_DEVIATION 13 • n=206 Participants
|
|
Sex: Female, Male
Female
|
266 Participants
n=99 Participants
|
248 Participants
n=107 Participants
|
514 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
230 Participants
n=99 Participants
|
256 Participants
n=107 Participants
|
486 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
496 participants
n=99 Participants
|
504 participants
n=107 Participants
|
1000 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From administration of initial drug dose until subject recovered from effects of sedationPopulation: This analysis was intention to treat (ITT) which is all subjects who enrolled and had data avaiable. The differences in total subjects enrolled and subjects analyzed are due to missing data.
AUCDesat measures desaturation as a function of incidence, magnitude, and duration. AUCDesat is the difference between the threshold and actual oxygen saturation measured every second. The total area below the 90% threshold is summated to determine AUCDesat in units of seconds\*percent.
Outcome measures
| Measure |
Sedation System
n=491 Participants
Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
|
Current Standard of Care
n=486 Participants
Site's current standard used for delivery of sedation
|
|---|---|---|
|
Area Under the Curve for Oxygen Desaturation (AUCDesat)
|
23.6 seconds*percent of oxygen desaturation
Interval 10.8 to 36.4
|
88.0 seconds*percent of oxygen desaturation
Interval 48.6 to 127.5
|
SECONDARY outcome
Timeframe: From first dose until subject recovered from effects of sedationPopulation: This analysis was intention to treat (ITT) which is all subjects who enrolled and had data avaiable. The differences in total subjects enrolled and subjects analyzed are due to missing data.
Duration of Modified Observers Assessment of Alertness and Sedation (MOAA/S)score of 0 or 1 MOAA/S is a scale of numbers ranging from 0-5, 5 being defined as being awake or minimally sedatied, and 0 defined as being at the deepest level of sedation (general anethesia). The mean MOAA/S score was the sum of each subject's scores during the procedure divided by the number of non-missing scores.
Outcome measures
| Measure |
Sedation System
n=491 Participants
Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
|
Current Standard of Care
n=495 Participants
Site's current standard used for delivery of sedation
|
|---|---|---|
|
Duration of Deep Sedation/General Anesthesia
|
0.1 minutes
Standard Deviation 1.0
|
0.1 minutes
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 24-48 hours post sedationPopulation: This analysis was intention to treat (ITT) which is all subjects who enrolled and had data avaiable. The differences in total subjects enrolled and subjects analyzed are due to missing data.
Patient Satisfaction with Sedation Instrument (PSSI) is a scale measuring patient satisfactin with the sedation they received. This validated scale consists of 16 questions that are scored and converted to a 0-100 scale, where 100 represented the most satisfied.
Outcome measures
| Measure |
Sedation System
n=392 Participants
Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
|
Current Standard of Care
n=397 Participants
Site's current standard used for delivery of sedation
|
|---|---|---|
|
Patient Satisfaction
|
92.3 Scores on a scale
Interval 91.0 to 93.5
|
89.7 Scores on a scale
Interval 88.5 to 91.0
|
SECONDARY outcome
Timeframe: Post procedurePopulation: This analysis was intention to treat (ITT) which is all subjects who enrolled and had data avaiable. The differences in total subjects enrolled and subjects analyzed are due to missing data.
Clinician Satisfaction with Sedation Instrument (CSSI) is a scale measuring the clinician satisfactin with the sedation they delivered. This validated scale consists of 16 questions that are scored and converted to a 0-100 scale, where 100 represented the most satisfied.
Outcome measures
| Measure |
Sedation System
n=490 Participants
Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
|
Current Standard of Care
n=491 Participants
Site's current standard used for delivery of sedation
|
|---|---|---|
|
Clinician Satisfaction
|
92.2 Scores on a scale
Interval 91.4 to 93.3
|
76.3 Scores on a scale
Interval 74.8 to 77.8
|
SECONDARY outcome
Timeframe: from "scope out" until first of two consecutive MOAA/S scores of 5Population: This analysis was intention to treat (ITT) which is all subjects who enrolled and had data avaiable. The differences in total subjects enrolled and subjects analyzed are due to missing data.
Recovery time- time for patient to reach first of two consecutive MOAA/S of 5 from the time scope was removed.
Outcome measures
| Measure |
Sedation System
n=463 Participants
Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
|
Current Standard of Care
n=465 Participants
Site's current standard used for delivery of sedation
|
|---|---|---|
|
Recovery Time (From Sedation)
|
2.9 minutes
Standard Deviation 2.4
|
6.5 minutes
Standard Deviation 7.0
|
Adverse Events
Sedation System
Current Standard of Care
Serious adverse events
| Measure |
Sedation System
n=489 participants at risk；n=496 participants at risk
Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
|
Current Standard of Care
n=504 participants at risk
Site's current standard used for delivery of sedation
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/496
|
0.20%
1/504 • Number of events 1
|
Other adverse events
| Measure |
Sedation System
n=489 participants at risk；n=496 participants at risk
Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
|
Current Standard of Care
n=504 participants at risk
Site's current standard used for delivery of sedation
|
|---|---|---|
|
Investigations
Decreased Oxygen Saturation
|
0.20%
1/489 • Number of events 1
|
5.4%
27/504 • Number of events 27
|
Additional Information
James Martin, PhD
Ethicon Endo-Surgery
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER