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Capnography During Upper GI Endoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andrea Riphaus, Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT01242345
First received: November 16, 2010
Last updated: November 20, 2011
Last verified: November 2010
History of Changes
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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

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

  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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01242345

Locations
Germany
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

Publications:

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

Keywords provided by Ruhr University of Bochum:
Hypoxemia
Capnography
Integrated pulmonary index
 Sedation
Propofol
Safety

ClinicalTrials.gov processed this record on May 19, 2013