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Capnography During Percutaneous Endoscopic Gastrostomy (PEG) (PEG)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2011 by Andrea Riphaus, Ruhr University of Bochum.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01242358
First Posted: November 17, 2010
Last Update Posted: November 22, 2011
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.
Information provided by (Responsible Party):
Andrea Riphaus, Ruhr University of Bochum
  Purpose
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.

Condition Intervention Phase
In the Study the Value of Capnography for Avoiding Complications During Sedation for PEG is Evaluated. Device: Capnography Device: Standard monitoring Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Clinical Value of Advanced Patient Monitoring Using Capnography With Analysis of the Integrated Pulmonary Index During Percutaneous Endoscopic Gastrostomy.

Further study details as provided by Andrea Riphaus, Ruhr University of Bochum:

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

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

Estimated Enrollment: 170
Study Start Date: June 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Capnography
Arm with capnographic monitoring
Device: Capnography
Capnographic monitoring
Placebo Comparator: Standard monitoring
Standard monitoring
Device: Standard monitoring
Standard monitoring

  Eligibility

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:

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

Exclusion Criteria:

  • No informed consent
  • ASA 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): NCT01242358


Contacts
Contact: Andrea Riphaus, MD +49-234-299 ext 80200 ariphaus@web.de

Locations
Germany
Ruhr Universität Bochum Recruiting
Bochum, Germany, 44892
Contact: Andrea Riphaus, MD    +49-234-299 ext 80200    ariphaus@web.de   
Principal Investigator: Andrea Riphaus, MD         
Technische Universität München Recruiting
München, Germany, 81675
Contact: Stefan von Delius,, MD         
Principal Investigator: Stefan von Delius, MD         
Deutsche Klinik für Diagnostik Recruiting
Wiesbaden, Germany, 65191
Contact: Till Wehrmann, Prof.         
Principal Investigator: Till Wehrmann, Prof.         
Sponsors and Collaborators
Ruhr University of Bochum
Investigators
Principal Investigator: Andrea Riphaus, MD Ruhr-Universität Bochum
  More Information

Publications:
Responsible Party: Andrea Riphaus, Clinical value of capnography During Percutaneous Endoscopic Gastrostomy (PEG), Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT01242358     History of Changes
Other Study ID Numbers: Capno-PEG 2010
First Submitted: November 16, 2010
First Posted: November 17, 2010
Last Update Posted: November 22, 2011
Last Verified: November 2011

Keywords provided by Andrea Riphaus, Ruhr University of Bochum:
hypoxaemia - capnography - integrated pulmonary index - PEG