Capnography During Percutaneous Endoscopic Gastrostomy (PEG)
PEG
Clinical Value of Advanced Patient Monitoring Using Capnography With Analysis of the Integrated Pulmonary Index During Percutaneous Endoscopic Gastrostomy.
1 other identifier
interventional
170
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2010
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 16, 2010
CompletedFirst Posted
Study publicly available on registry
November 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedNovember 22, 2011
November 1, 2011
1.5 years
November 16, 2010
November 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hypoxemia
From the beginning to the end of the PEG procedure, i.e. from 0h to approximately 2h
Secondary Outcomes (1)
Further complications
From the beginning to the end of the PEG procedure, i.e. from 0h to approximately 2h
Study Arms (2)
Capnography
EXPERIMENTALArm with capnographic monitoring
Standard monitoring
PLACEBO COMPARATORStandard monitoring
Interventions
Eligibility Criteria
You may qualify if:
- Years and older
- Scheduled for PEG with propofol sedation
You may not qualify if:
- No informed consent
- ASA V
- Emergency endoscopy
- Preexisting hypotension, bradycardia or hypoxemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Ruhr Universität Bochum
Bochum, 44892, Germany
Technische Universität München
München, 81675, Germany
Deutsche Klinik für Diagnostik
Wiesbaden, 65191, Germany
Related Publications (1)
Vargo JJ, Zuccaro G Jr, Dumot JA, Conwell DL, Morrow JB, Shay SS. Automated graphic assessment of respiratory activity is superior to pulse oximetry and visual assessment for the detection of early respiratory depression during therapeutic upper endoscopy. Gastrointest Endosc. 2002 Jun;55(7):826-31. doi: 10.1067/mge.2002.124208.
PMID: 12024135RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Riphaus, MD
Ruhr-Universität Bochum
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical value of capnography During Percutaneous Endoscopic Gastrostomy (PEG)
Study Record Dates
First Submitted
November 16, 2010
First Posted
November 17, 2010
Study Start
June 1, 2010
Primary Completion
December 1, 2011
Study Completion
March 1, 2012
Last Updated
November 22, 2011
Record last verified: 2011-11