- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01072487
Capnography During Colonoscopy (ColoCap)
February 2, 2011 updated by: Technical University of Munich
Capnography as an Adjunct to Standard Monitoring During Midazolam and Propofol Sedation for Colonoscopy
In the study the value of capnography for avoiding complications during sedation for colonoscopy is evaluated.
Study Overview
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)
760
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
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-
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Bochum, Germany, 44892
- Knappschaftskrankenhaus der Ruhr-Universität Bochum
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Wiesbaden, Germany, 65191
- Deutsche Klinik für Diagnostik
-
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Bavaria
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Munich, Bavaria, Germany, 81675
- Technische Universität München
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-
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
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age>=18
- Scheduled for colonoscopy with midazolam and propofol sedation
Exclusion Criteria:
- No informed consent
- ASA IV or 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
|
Monitoring of the capnography curve for early detection of apnea
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No Intervention: Standard
Standard monitoring.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hypoxemia
Time Frame: From the start to the end of colonoscopy, i.e. from 0 h to approximately 2 h
|
From the start to the end of colonoscopy, i.e. from 0 h to approximately 2 h
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Further complications
Time Frame: From the start to the end of colonoscopy, i.e. from 0 h to approximately 2 h
|
From the start to the end of colonoscopy, i.e. from 0 h to approximately 2 h
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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 Registration Dates
First Submitted
February 17, 2010
First Submitted That Met QC Criteria
February 19, 2010
First Posted (Estimate)
February 22, 2010
Study Record Updates
Last Update Posted (Estimate)
February 3, 2011
Last Update Submitted That Met QC Criteria
February 2, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2681/10
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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