Safety and Effectiveness of a Computer-Assisted Personalized Sedation (CAPS) Device for Propofol Delivery During Endoscopy

Phase 3

Completed

Interventions: Device: Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System)
Other: benzodiazepines and opioid sedation

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Sedation System	Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System)	Computer-Assisted Personalized Sedation (CAPS) device used for delivery of sedation
Current Standard of Care	benzodiazepines and opioid sedation	Site's current standard used for delivery of sedation

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Locations (7): Metropolitan Gastroenterology Group, PC
🇺🇸
Washington, District of Columbia, United States
Digestive Health Specialists
🇺🇸
Tacoma, Washington, United States
Digestive Health Specialists, PA
🇺🇸
Winston-Salem, North Carolina, United States
The Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Fayetteville Gastroenterology Associates, PA
🇺🇸
Fayetteville, North Carolina, United States
Charlottesville Medical Research
🇺🇸
Charlottesville, Virginia, United States
Nashville Medical Research Institute
🇺🇸
Nashville, Tennessee, United States