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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Colonoscopy, Endoscopy, Digestive System, Conscious Sedation

Intervention / Treatment
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* Device: Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System)
* Other: benzodiazepines and opioid sedation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sedation System<br>Computer-Assisted Personalized Sedation (CAPS) device used for delivery of sedation | Device: Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System)<br>* propofol sedation per device instructions for use<br>|
| Active Comparator: Current Standard of Care<br>Site's current standard used for delivery of sedation | Other: benzodiazepines and opioid sedation<br>* per site's current standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Propofol, Diprivan, Colonoscopy, Endoscopy, Digestive System, Conscious Sedation