Capnography During Upper GI Endoscopy

November 20, 2011 updated by: Andrea Riphaus, Ruhr University of Bochum

Clinical Value of Advanced Patient Monitoring With Capnography and Analysis of the Integrated Pulmonary Index During Interventional Upper Gastrointestinale Endoscopy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bochum, Germany, 44892
        • Ruhr Universitat Bochum
      • München, Germany, 81675
        • Technische Universität München
      • Wiesbaden, Germany, 65191
        • Deutsche Klinik für Diagnostik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hypoxemia
Time Frame: From the start to the end of endoscopy, i.e. from 0 h to approximately 2 h
From the start to the end of endoscopy, i.e. from 0 h to approximately 2 h

Secondary Outcome Measures

Outcome Measure
Time Frame
Further complications
Time Frame: From the start to the end of endoscopy, i.e. from 0 h to approximately 2 h
From the start to the end of endoscopy, i.e. from 0 h to approximately 2 h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruhr University of Bochum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

November 16, 2010

First Submitted That Met QC Criteria

November 16, 2010

First Posted (Estimate)

November 17, 2010

Study Record Updates

Last Update Posted (Estimate)

November 22, 2011

Last Update Submitted That Met QC Criteria

November 20, 2011

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Capno-Interventional 2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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