Capnography During Percutaneous Endoscopic Gastrostomy (PEG) (PEG)

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

Clinical Value of Advanced Patient Monitoring Using Capnography With Analysis of the Integrated Pulmonary Index During Percutaneous Endoscopic Gastrostomy.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

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
        • Recruiting
        • Ruhr Universitat Bochum
        • Contact:
          • Andrea Riphaus, MD
          • Phone Number: 80200 +49-234-299
          • Email: ariphaus@web.de
        • Principal Investigator:
          • Andrea Riphaus, MD
      • München, Germany, 81675
        • Recruiting
        • Technische Universität München
        • Contact:
          • Stefan von Delius,, MD
      • Wiesbaden, Germany, 65191
        • Recruiting
        • Deutsche Klinik für Diagnostik
        • Contact:
          • Till Wehrmann, Prof.
        • Principal Investigator:
          • Till Wehrmann, Prof.

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:

  • 18 Years and older
  • Scheduled for PEG with propofol sedation

Exclusion Criteria:

  • No informed consent
  • ASA 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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Capnography
Arm with capnographic monitoring
Device: Capnography
Capnographic monitoring
PLACEBO_COMPARATOR: Standard monitoring
Device: Standard monitoring
Standard monitoring

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Ruhr University of Bochum

Investigators

  • Principal Investigator: Andrea Riphaus, MD, Ruhr-Universität 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 (ANTICIPATED)

December 1, 2011

Study Completion (ANTICIPATED)

March 1, 2012

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, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Capno-PEG 2010

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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