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Capnography During Colonoscopy (ColoCap)

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ClinicalTrials.gov Identifier: NCT01072487
Recruitment Status : Completed
First Posted : February 22, 2010
Last Update Posted : February 3, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
In the study the value of capnography for avoiding complications during sedation for colonoscopy is evaluated.

Condition or disease Intervention/treatment Phase
Hypoxemia Complications Procedure: Capnography Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 760 participants
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 Colonoscopy
Study Start Date : February 2010
Primary Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Capnography
Arm with capnographic monitoring
Procedure: Capnography
Monitoring of the capnography curve for early detection of apnea
No Intervention: Standard
Standard monitoring.


Outcome Measures

Primary Outcome Measures :
  1. Hypoxemia [ Time Frame: From the start to the end of colonoscopy, i.e. from 0 h to approximately 2 h ]

Secondary Outcome Measures :
  1. Further complications [ Time Frame: From the start to the end of colonoscopy, i.e. from 0 h to approximately 2 h ]

Eligibility Criteria

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:   Yes
Criteria

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
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): NCT01072487


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:
Responsible Party: Stefan von Delius, II. Medizinische Klinik der Technischen Universität München
ClinicalTrials.gov Identifier: NCT01072487     History of Changes
Other Study ID Numbers: 2681/10
First Posted: February 22, 2010    Key Record Dates
Last Update Posted: February 3, 2011
Last Verified: February 2011

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

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