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Capnography During ERCP (EndoBreath)

This study has been completed.
Sponsor:
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01072474
First received: February 18, 2010
Last updated: August 23, 2012
Last verified: August 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
II. Medizinische Klinik der Technischen Universität München  This link exits the ClinicalTrials.gov site

Publications:

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
Study First Received: February 18, 2010
Last Updated: August 23, 2012
Health Authority: Germany: Ethikkommission der Fakultät für Medizin der Technischen Universität München

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

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

ClinicalTrials.gov processed this record on May 16, 2013