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Capnography During ERCP (EndoBreath)

This study has been completed.
Information provided by:
Technische Universität München Identifier:
First received: February 18, 2010
Last updated: August 23, 2012
Last verified: August 2012
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.

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01072474

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
Principal Investigator: Stefan von Delius, MD Technische Universität München
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Stefan von Delius, II. Medizinische Klinik der Technischen Universität München Identifier: NCT01072474     History of Changes
Other Study ID Numbers: 2680/10
Study First Received: February 18, 2010
Last Updated: August 23, 2012

Keywords provided by Technische Universität München:
Gastrointestinal endoscopy

Additional relevant MeSH terms:
Signs and Symptoms, Respiratory
Signs and Symptoms processed this record on August 23, 2017