Multi-center Pivotal Clinical Trial to Compare the Safety and Effectiveness of Procedural Sedation in GI Endoscopy: A Computer-Assisted Personalized Sedation (CAPS) Device Versus Current Standard of Care
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Colonoscopy
- Sponsor
- Ethicon Endo-Surgery
- Enrollment
- 1000
- Locations
- 7
- Primary Endpoint
- Area Under the Curve for Oxygen Desaturation (AUCDesat)
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
Area Under the Curve for Oxygen Desaturation (AUCDesat)
Time Frame: 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 Outcomes
- Duration of Deep Sedation/General Anesthesia(From first dose until subject recovered from effects of sedation)
- Patient Satisfaction(24-48 hours post sedation)
- Clinician Satisfaction(Post procedure)
- Recovery Time (From Sedation)(from "scope out" until first of two consecutive MOAA/S scores of 5)