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Capnography During Percutaneous Endoscopic Gastrostomy (PEG)

This study is currently recruiting participants.
Verified November 2011 by Ruhr University of Bochum
Sponsor:
Information provided by (Responsible Party):
Andrea Riphaus, Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT01242358
First received: November 16, 2010
Last updated: November 20, 2011
Last verified: November 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Clinical Value of Advanced Patient Monitoring Using Capnography With Analysis of the Integrated Pulmonary Index During Percutaneous Endoscopic Gastrostomy.

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 beginning to the end of the PEG procedure, i.e. from 0h to approximately 2h ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: November 16, 2010
Last Updated: November 20, 2011
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on May 19, 2013