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Capnography During Upper GI Endoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01242345
Recruitment Status : Completed
First Posted : November 17, 2010
Last Update Posted : November 22, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Capnography as an Adjunct to Standard Monitoring During Midazolam and Propofol Sedation for Interventional Upper GI Endoscopy Device: Capnography Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : June 2010
Primary Completion Date : November 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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

Secondary Outcome Measures :
  1. Further complications [ Time Frame: From the start to the end of endoscopy, 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 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

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): 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
First Posted: November 17, 2010    Key Record Dates
Last Update Posted: November 22, 2011
Last Verified: November 2010

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