Capnography During Colonoscopy (ColoCap)

This study has been completed.
Sponsor:
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01072487
First received: February 17, 2010
Last updated: February 2, 2011
Last verified: February 2011
  Purpose

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
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 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 ] [ Designated as safety issue: Yes ]

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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: February 17, 2010
Last Updated: February 2, 2011
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 July 24, 2014