Safety and Effectiveness of a Computer-Assisted Personalized Sedation (CAPS) Device for Propofol Delivery During Endoscopy
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
1 other identifier
interventional
1,000
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2007
Shorter than P25 for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 26, 2007
CompletedFirst Posted
Study publicly available on registry
March 27, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedResults Posted
Study results publicly available
January 25, 2011
CompletedJanuary 25, 2011
December 1, 2010
7 months
March 26, 2007
October 6, 2010
December 30, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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
Study Arms (2)
Sedation System
EXPERIMENTALComputer-Assisted Personalized Sedation (CAPS) device used for delivery of sedation
Current Standard of Care
ACTIVE COMPARATORSite's current standard used for delivery of sedation
Interventions
propofol sedation per device instructions for use
Eligibility Criteria
You may qualify if:
- ≥ 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Metropolitan Gastroenterology Group, PC
Washington D.C., District of Columbia, 20006, United States
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
Related Publications (1)
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.
PMID: 21168841DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- James Martin, PhD
- Organization
- Ethicon Endo-Surgery
Study Officials
- STUDY DIRECTOR
James Martin, PhD
Ethicon Endo-Surgery, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 26, 2007
First Posted
March 27, 2007
Study Start
March 1, 2007
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
January 25, 2011
Results First Posted
January 25, 2011
Record last verified: 2010-12