Safety and Effectiveness of a Computer-Assisted Personalized Sedation (CAPS) Device for Propofol Delivery During Endoscopy
Study Details
Study Description
Brief Summary
Patients routinely receive sedation during a colonoscopy or upper endoscopy (esophagogastroduodenoscopy; EGD) procedure. Propofol is a sedative that can be used during these procedures. The purpose of this study is to determine if this CAPS device enables a physician/registered nurse (RN) team to safely and effectively administer propofol sedation during colonoscopy or EGD procedures relative to current sedation practices.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sedation System Computer-Assisted Personalized Sedation (CAPS) device used for delivery of sedation |
Device: Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System)
propofol sedation per device instructions for use
|
| Active Comparator: Current Standard of Care Site's current standard used for delivery of sedation |
Other: benzodiazepines and opioid sedation
per site's current standard of care
|
Outcome Measures
Primary Outcome Measures
- Area Under the Curve for Oxygen Desaturation (AUCDesat) [From administration of initial drug dose until subject recovered from effects of sedation]
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.
Secondary Outcome Measures
- Duration of Deep Sedation/General Anesthesia [From first dose until subject recovered from effects of sedation]
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.
- Patient Satisfaction [24-48 hours post sedation]
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.
- Clinician Satisfaction [Post procedure]
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.
- Recovery Time (From Sedation) [from "scope out" until first of two consecutive MOAA/S scores of 5]
Recovery time- time for patient to reach first of two consecutive MOAA/S of 5 from the time scope was removed.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
≥ 18 years old
-
Able to comprehend, sign, and date the written informed consent form
-
English as primary language
-
Undergoing a non-emergent EGD or colonoscopy
-
Have taken nothing by mouth for a minimum of 6 hours prior to the study procedure
-
American Society of Anesthesiologists (ASA) Class I, II or III
Exclusion Criteria:
-
Allergy or inability to tolerate study medications or components of study medications
-
Investigator anticipates greater than 45 minute procedure time due to known anatomical difficulty
-
Currently using a fentanyl patch
-
History of diagnosed sleep apnea
-
History of diagnosed gastroparesis
-
Baseline oxygen saturation < 90% (room air)
-
Pregnant or nursing females
-
Body mass index (BMI) ≥ 35
-
Participation in a clinical trial within the past 30 days.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Metropolitan Gastroenterology Group, PC | Washington | District of Columbia | United States | 20006 |
| 2 | Fayetteville Gastroenterology Associates, PA | Fayetteville | North Carolina | United States | 28304 |
| 3 | Digestive Health Specialists, PA | Winston-Salem | North Carolina | United States | 27103 |
| 4 | The Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 5 | Nashville Medical Research Institute | Nashville | Tennessee | United States | 37205 |
| 6 | Charlottesville Medical Research | Charlottesville | Virginia | United States | 22911 |
| 7 | Digestive Health Specialists | Tacoma | Washington | United States | 98405 |
Sponsors and Collaborators
- Ethicon Endo-Surgery
Investigators
- Study Director: James Martin, PhD, Ethicon Endo-Surgery, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CI-06-0004
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Sedation System | Current Standard of Care |
|---|---|---|
| Arm/Group Description | Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation | Site's current standard used for delivery of sedation |
| Period Title: Overall Study | ||
| STARTED | 496 | 504 |
| COMPLETED | 489 | 493 |
| NOT COMPLETED | 7 | 11 |
Baseline Characteristics
| Arm/Group Title | Sedation System | Current Standard of Care | Total |
|---|---|---|---|
| Arm/Group Description | Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation | Site's current standard used for delivery of sedation | Total of all reporting groups |
| Overall Participants | 496 | 504 | 1000 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
53
(13)
|
53
(14)
|
53
(13)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
266
53.6%
|
248
49.2%
|
514
51.4%
|
| Male |
230
46.4%
|
256
50.8%
|
486
48.6%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
496
100%
|
504
100%
|
1000
100%
|
Outcome Measures
| Title | Area Under the Curve for Oxygen Desaturation (AUCDesat) |
|---|---|
| Description | 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. |
| Time Frame | From administration of initial drug dose until subject recovered from effects of sedation |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Sedation System | Current Standard of Care |
|---|---|---|
| Arm/Group Description | Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation | Site's current standard used for delivery of sedation |
| Measure Participants | 491 | 486 |
| Mean (95% Confidence Interval) [seconds*percent of oxygen desaturation] |
23.6
|
88.0
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Sedation System, Current Standard of Care |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.028 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Duration of Deep Sedation/General Anesthesia |
|---|---|
| Description | 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. |
| Time Frame | From first dose until subject recovered from effects of sedation |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Sedation System | Current Standard of Care |
|---|---|---|
| Arm/Group Description | Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation | Site's current standard used for delivery of sedation |
| Measure Participants | 491 | 495 |
| Mean (Standard Deviation) [minutes] |
0.1
(1.0)
|
0.1
(1.1)
|
| Title | Patient Satisfaction |
|---|---|
| Description | 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. |
| Time Frame | 24-48 hours post sedation |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Sedation System | Current Standard of Care |
|---|---|---|
| Arm/Group Description | Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation | Site's current standard used for delivery of sedation |
| Measure Participants | 392 | 397 |
| Mean (95% Confidence Interval) [Scores on a scale] |
92.3
|
89.7
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Sedation System, Current Standard of Care |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.007 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Clinician Satisfaction |
|---|---|
| Description | 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. |
| Time Frame | Post procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Sedation System | Current Standard of Care |
|---|---|---|
| Arm/Group Description | Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation | Site's current standard used for delivery of sedation |
| Measure Participants | 490 | 491 |
| Mean (95% Confidence Interval) [Scores on a scale] |
92.2
|
76.3
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Sedation System, Current Standard of Care |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Recovery Time (From Sedation) |
|---|---|
| Description | Recovery time- time for patient to reach first of two consecutive MOAA/S of 5 from the time scope was removed. |
| Time Frame | from "scope out" until first of two consecutive MOAA/S scores of 5 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Sedation System | Current Standard of Care |
|---|---|---|
| Arm/Group Description | Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation | Site's current standard used for delivery of sedation |
| Measure Participants | 463 | 465 |
| Mean (Standard Deviation) [minutes] |
2.9
(2.4)
|
6.5
(7.0)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Sedation System | Current Standard of Care | ||
| Arm/Group Description | Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation | Site's current standard used for delivery of sedation | ||
All Cause Mortality |
||||
| Sedation System | Current Standard of Care | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Sedation System | Current Standard of Care | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/496 (0%) | 1/504 (0.2%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 0/496 (0%) | 0 | 1/504 (0.2%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Sedation System | Current Standard of Care | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/489 (0.2%) | 27/504 (5.4%) | ||
| Investigations | ||||
| Decreased Oxygen Saturation | 1/489 (0.2%) | 1 | 27/504 (5.4%) | 27 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | James Martin, PhD |
|---|---|
| Organization | Ethicon Endo-Surgery |
| Phone | 513 337-7000 |
- CI-06-0004