Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Use of Capnography in EGD and Colonoscopy With Moderate Sedation.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01994785
Recruitment Status : Completed
First Posted : November 26, 2013
Results First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Collaborator:
American College of Gastroenterology
Information provided by (Responsible Party):
John Vargo, The Cleveland Clinic

Brief Summary:
This study will provide capnography monitoring during routine upper endoscopy and colonoscopy with moderate sedation in order to see if it improves safety.

Condition or disease Intervention/treatment Phase
Hypoxia Apnea Hypotension Hypopnea Diagnostic Test: Capnographic Monitoring Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 452 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Other
Official Title: Does the Use of Capnography in Routine EGD and Colonoscopy Targeting Moderate Sedation With a Benzodiazepine and Opioid Improve Safety?
Study Start Date : November 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Active Comparator: EGD capnography open
Capnographic monitoring during EGD - Data made available to study staff throughout procedure
Diagnostic Test: Capnographic Monitoring
Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring

Active Comparator: EGD capnography blinded
Capnographic monitoring during EGD - Data made available to study staff only if necessary for safety reasons
Diagnostic Test: Capnographic Monitoring
Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring

Active Comparator: Colonoscopy capnography open
Capnographic monitoring during Colonoscopy - Data made available to study staff throughout procedure
Diagnostic Test: Capnographic Monitoring
Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring

Active Comparator: Colonoscopy capnography blinded
Capnographic monitoring during Colonoscopy - Data made available to study staff only if necessary for safety reasons
Diagnostic Test: Capnographic Monitoring
Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring




Primary Outcome Measures :
  1. Number of Participants Experiencing Hypoxia During Capnography Monitoring. [ Time Frame: One day--data is collected during one endoscopic procedure. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >18yrs with full decision making capacity
  • Scheduled for elective upper endoscopy or colonoscopy with moderate sedation

Exclusion Criteria:

  • ASAPS class III or higher.
  • History of a demonstrated allergy or intolerance to a benzodiazepine or opioid
  • Patients scheduled for both upper endoscopy and colonoscopy during the same endoscopy day

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994785


Locations
Layout table for location information
United States, Ohio
Cleveland Clinic
Independence, Ohio, United States, 44131
Sponsors and Collaborators
The Cleveland Clinic
American College of Gastroenterology
Investigators
Layout table for investigator information
Principal Investigator: John J Vargo, MD The Cleveland Clinic
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: John Vargo, Department Chairman, Gastroenterology and Hepatology, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01994785    
Other Study ID Numbers: CC-13-792
First Posted: November 26, 2013    Key Record Dates
Results First Posted: July 2, 2017
Last Update Posted: July 2, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by John Vargo, The Cleveland Clinic:
Sedation
Endoscopy
Capnography
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypotension
Hypoxia
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms, Respiratory