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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
1,000
propofol sedation per device instructions for use
per site's current standard of care
Metropolitan Gastroenterology Group, PC
Washington D.C., District of Columbia, United States
Fayetteville Gastroenterology Associates, PA
Fayetteville, North Carolina, United States
Digestive Health Specialists, PA
Winston-Salem, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Nashville Medical Research Institute
Nashville, Tennessee, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
Digestive Health Specialists
Tacoma, Washington, United States
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.
Time frame: From administration of initial drug dose until subject recovered from effects of sedation
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: from "scope out" until first of two consecutive MOAA/S scores of 5
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