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

December 30, 2010 updated by: Ethicon Endo-Surgery

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20006
        • Metropolitan Gastroenterology Group, PC
    • North Carolina
      • Fayetteville, North Carolina, United States, 28304
        • Fayetteville Gastroenterology Associates, PA
      • Winston-Salem, North Carolina, United States, 27103
        • Digestive Health Specialists, PA
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Nashville Medical Research Institute
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Charlottesville Medical Research
    • Washington
      • Tacoma, Washington, United States, 98405
        • Digestive Health Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: 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.
From first dose until subject recovered from effects of sedation
Patient Satisfaction
Time Frame: 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.
24-48 hours post sedation
Clinician Satisfaction
Time Frame: 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.
Post procedure
Recovery Time (From Sedation)
Time Frame: 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.
from "scope out" until first of two consecutive MOAA/S scores of 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ethicon Endo-Surgery

Investigators

  • Study Director: James Martin, PhD, Ethicon Endo-Surgery, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

March 26, 2007

First Submitted That Met QC Criteria

March 26, 2007

First Posted (Estimate)

March 27, 2007

Study Record Updates

Last Update Posted (Estimate)

January 25, 2011

Last Update Submitted That Met QC Criteria

December 30, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CI-06-0004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colonoscopy

Clinical Trials on Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe