Study:
Does Capnography Prevent Hypoxemia During ERCP and EUS? A Randomized, Controlled Trial
Rationale:
n/a
Purpose:
Subjects undergoing elective ERCP and EUS will receive standard monitoring and sedation. In
addition, capnography which measures carbon dioxide levels and can graphically assess
respiratory activity will be used. Subjects will be randomized to either a capnography
blinded or titration arm. In the capnography titration arm, the endoscopy team would be made
aware of capnographic abnormalities as they arise throughout the procedure. In the
capnography blinded arm, this information will not be available to the endoscopy team and
represents standard of care. It is our hypothesis that using capnography can prevent low
oxygen levels known as hypoxemia, during these procedures.
Study Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Hypoxemia |
Device: Capnography (Specific device name: Capnostream 20)
Device: Sham |
N/A |
Verified by
The Cleveland Clinic
September, 2010
Sponsored by: The Cleveland Clinic
Information provided by: The Cleveland Clinic
ClinicalTrials.gov identifier: NCT00675415
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
John J Vargo, M.D., M.P.H.., Principal Investigator