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Capnography During Colonoscopy (ColoCap)

This study has been completed.
Information provided by:
Technische Universität München Identifier:
First received: February 17, 2010
Last updated: February 2, 2011
Last verified: February 2011
In the study the value of capnography for avoiding complications during sedation for colonoscopy is evaluated.

Condition Intervention Phase
Hypoxemia Complications Procedure: Capnography 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 Colonoscopy

Resource links provided by NLM:

Further study details as provided by Technische Universität München:

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

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

Estimated Enrollment: 760
Study Start Date: February 2010
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Capnography
Arm with capnographic monitoring
Procedure: Capnography
Monitoring of the capnography curve for early detection of apnea
No Intervention: Standard
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:   Yes

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
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Please refer to this study by its identifier: NCT01072487

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:
Responsible Party: Stefan von Delius, II. Medizinische Klinik der Technischen Universität München Identifier: NCT01072487     History of Changes
Other Study ID Numbers: 2681/10
Study First Received: February 17, 2010
Last Updated: February 2, 2011

Keywords provided by Technische Universität München:
Gastrointestinal endoscopy

Additional relevant MeSH terms:
Signs and Symptoms, Respiratory
Signs and Symptoms processed this record on August 17, 2017