Capnography During ERCP (EndoBreath)

August 23, 2012 updated by: Technical University of Munich

Capnography as an Adjunct to Standard Monitoring During Midazolam and Propofol Sedation for ERCP

In the study the value of capnography for avoiding complications during sedation for ERCP is evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

242

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bochum, Germany, 44892
        • Knappschaftskrankenhaus der Ruhr-Universität Bochum
      • Wiesbaden, Germany, 65191
        • Deutsche Klinik für Diagnostik
    • Bavaria
      • Munich, Bavaria, Germany, 81675
        • Technische Universität München

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Capnography
Arm with capnographic monitoring
Procedure: Capnography
Capnographic monitoring
Placebo Comparator: Standard
Standard monitoring.
Procedure: Standard monitoring
Standard monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hypoxemia
Time Frame: From the beginning to the end of the ERCP procedure, i.e. from 0h to approximately 2h
From the beginning to the end of the ERCP procedure, i.e. from 0h to approximately 2h

Secondary Outcome Measures

Outcome Measure
Time Frame
Further complications
Time Frame: From the beginning to the end of the ERCP procedure, i.e. from 0h to approximately 2h
From the beginning to the end of the ERCP procedure, i.e. from 0h to approximately 2h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Investigators

  • Principal Investigator: Stefan von Delius, MD, Technical University of Munich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

February 18, 2010

First Submitted That Met QC Criteria

February 19, 2010

First Posted (Estimate)

February 22, 2010

Study Record Updates

Last Update Posted (Estimate)

August 24, 2012

Last Update Submitted That Met QC Criteria

August 23, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2680/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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