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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sedation System | Experimental | Computer-Assisted Personalized Sedation (CAPS) device used for delivery of sedation |
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| Current Standard of Care | Active Comparator | Site's current standard used for delivery of sedation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System) | Device | propofol sedation per device instructions for use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve for Oxygen Desaturation (AUCDesat) | 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. | From administration of initial drug dose until subject recovered from effects of sedation |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Deep Sedation/General Anesthesia | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Martin, PhD | Ethicon Endo-Surgery, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metropolitan Gastroenterology Group, PC | Washington D.C. | District of Columbia | 20006 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21168841 | Derived | Pambianco DJ, Vargo JJ, Pruitt RE, Hardi R, Martin JF. Computer-assisted personalized sedation for upper endoscopy and colonoscopy: a comparative, multicenter randomized study. Gastrointest Endosc. 2011 Apr;73(4):765-72. doi: 10.1016/j.gie.2010.10.031. Epub 2010 Dec 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sedation System | Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation |
| FG001 | Current Standard of Care | Site's current standard used for delivery of sedation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| benzodiazepines and opioid sedation | Other | per site's current standard of care |
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| From first dose until subject recovered from effects of sedation |
| Patient Satisfaction | 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. | 24-48 hours post sedation |
| Clinician Satisfaction | 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. | Post procedure |
| Recovery Time (From Sedation) | Recovery time- time for patient to reach first of two consecutive MOAA/S of 5 from the time scope was removed. | from "scope out" until first of two consecutive MOAA/S scores of 5 |
| Fayetteville Gastroenterology Associates, PA |
| Fayetteville |
| North Carolina |
| 28304 |
| United States |
| Digestive Health Specialists, PA | Winston-Salem | North Carolina | 27103 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Nashville Medical Research Institute | Nashville | Tennessee | 37205 | United States |
| Charlottesville Medical Research | Charlottesville | Virginia | 22911 | United States |
| Digestive Health Specialists | Tacoma | Washington | 98405 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sedation System | Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation |
| BG001 | Current Standard of Care | Site's current standard used for delivery of sedation |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Area Under the Curve for Oxygen Desaturation (AUCDesat) | 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. | 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. | Posted | Mean | 95% Confidence Interval | seconds*percent of oxygen desaturation | From administration of initial drug dose until subject recovered from effects of sedation |
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| Secondary | Duration of Deep Sedation/General Anesthesia | 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. | 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. | Posted | Mean | Standard Deviation | minutes | From first dose until subject recovered from effects of sedation |
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| Secondary | Patient Satisfaction | 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. | 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. | Posted | Mean | 95% Confidence Interval | Scores on a scale | 24-48 hours post sedation |
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| Secondary | Clinician Satisfaction | 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. | 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. | Posted | Mean | 95% Confidence Interval | Scores on a scale | Post procedure |
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| Secondary | Recovery Time (From Sedation) | Recovery time- time for patient to reach first of two consecutive MOAA/S of 5 from the time scope was removed. | 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. | Posted | Mean | Standard Deviation | minutes | from "scope out" until first of two consecutive MOAA/S scores of 5 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sedation System | Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation | 0 | 496 | 1 | 489 | ||
| EG001 | Current Standard of Care | Site's current standard used for delivery of sedation | 1 | 504 | 27 | 504 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment | hospitalization for abdominal pain, nausea and vomiting post colonoscopy |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased Oxygen Saturation | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Martin, PhD | Ethicon Endo-Surgery | 513 337-7000 |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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