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Capnography During Upper GI Endoscopy

This study has been completed.
Information provided by (Responsible Party):
Andrea Riphaus, Ruhr University of Bochum Identifier:
First received: November 16, 2010
Last updated: November 20, 2011
Last verified: November 2010
In this randomized controlled trial the utility of capnography and IPI 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.

Condition Intervention Phase
Capnography as an Adjunct to Standard Monitoring During Midazolam and Propofol Sedation for Interventional Upper GI Endoscopy
Device: Capnography
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Prevention
Official Title: Clinical Value of Advanced Patient Monitoring With Capnography and Analysis of the Integrated Pulmonary Index During Interventional Upper Gastrointestinale Endoscopy

Resource links provided by NLM:

Further study details as provided by Ruhr University of Bochum:

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

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

Enrollment: 170
Study Start Date: June 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No Intervention
Standard monitoring.
Experimental: Capnography
Arm with capnographic monitoring
Device: Capnography
Monitoring of the capnography curve for early detection of apnea


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 interventional upper GI endoscopy with midazolam and propofol sedation

Exclusion Criteria:

  • No informed consent
  • ASA IV or V
  • Emergency endoscopy
  • Preexisting hypotension, bradycardia or hypoxemia
  Contacts and Locations
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Please refer to this study by its identifier: NCT01242345

Ruhr Universität Bochum
Bochum, Germany, 44892
Technische Universität München
München, Germany, 81675
Deutsche Klinik für Diagnostik
Wiesbaden, Germany, 65191
Sponsors and Collaborators
Ruhr University of Bochum
  More Information

Responsible Party: Andrea Riphaus, Capnography During Upper GI Endoscopy, Ruhr University of Bochum Identifier: NCT01242345     History of Changes
Other Study ID Numbers: Capno-Interventional 2011
Study First Received: November 16, 2010
Last Updated: November 20, 2011

Keywords provided by Ruhr University of Bochum:
Integrated pulmonary index
Safety processed this record on April 28, 2017