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Capnography During ERCP (EndoBreath)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01072474
First Posted: February 22, 2010
Last Update Posted: August 24, 2012
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.
Information provided by:
Technische Universität München
  Purpose
In the study the value of capnography for avoiding complications during sedation for ERCP is evaluated.

Condition Intervention Phase
Hypoxemia Complications Procedure: Capnography Procedure: Standard monitoring Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Capnography as an Adjunct to Standard Monitoring During Midazolam and Propofol Sedation for ERCP

Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Hypoxemia [ Time Frame: From the beginning to the end of the ERCP procedure, i.e. from 0h to approximately 2h ]

Secondary Outcome Measures:
  • Further complications [ Time Frame: From the beginning to the end of the ERCP procedure, i.e. from 0h to approximately 2h ]

Estimated Enrollment: 242
Study Start Date: February 2010
Study Completion Date: March 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Capnography
Arm with capnographic monitoring
Procedure: Capnography
Capnographic monitoring
Placebo Comparator: Standard
Standard monitoring.
Procedure: Standard monitoring
Standard monitoring

Detailed Description:
In this randomized controlled trial the utility of capnography gets evaluated. Hypoxemia may occur during sedation with midazolam and propofol. Whether hypoxemia may be prevented by an additional capnographic monitoring is subject of the study.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age>=18
  • Scheduled for colonoscopy with midazolam and propofol sedation

Exclusion Criteria:

  • No informed consent
  • ASA V
  • Pregnancy
  • Prexisting hypotension, bradycardia or hypoxemia
  Contacts and Locations
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): NCT01072474


Locations
Germany
Technische Universität München
Munich, Bavaria, Germany, 81675
Knappschaftskrankenhaus der Ruhr-Universität Bochum
Bochum, Germany, 44892
Deutsche Klinik für Diagnostik
Wiesbaden, Germany, 65191
Sponsors and Collaborators
Technische Universität München
Investigators
Principal Investigator: Stefan von Delius, MD Technische Universität München
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stefan von Delius, II. Medizinische Klinik der Technischen Universität München
ClinicalTrials.gov Identifier: NCT01072474     History of Changes
Other Study ID Numbers: 2680/10
First Submitted: February 18, 2010
First Posted: February 22, 2010
Last Update Posted: August 24, 2012
Last Verified: August 2012

Keywords provided by Technische Universität München:
Safety
Sedation
Gastrointestinal endoscopy
Colonoscopy

Additional relevant MeSH terms:
Anoxia
Signs and Symptoms, Respiratory
Signs and Symptoms