Capnography During Upper GI Endoscopy
Clinical Value of Advanced Patient Monitoring With Capnography and Analysis of the Integrated Pulmonary Index During Interventional Upper Gastrointestinale Endoscopy
1 other identifier
interventional
170
1 country
3
Brief Summary
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.
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
Click on a node to explore related trials.
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
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedNovember 22, 2011
November 1, 2010
1.4 years
November 16, 2010
November 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hypoxemia
From the start to the end of endoscopy, i.e. from 0 h to approximately 2 h
Secondary Outcomes (1)
Further complications
From the start to the end of endoscopy, i.e. from 0 h to approximately 2 h
Study Arms (2)
No Intervention
NO INTERVENTIONStandard monitoring.
Capnography
EXPERIMENTALArm with capnographic monitoring
Interventions
Eligibility Criteria
You may qualify if:
- Age\>=18
- Scheduled for interventional upper GI endoscopy with midazolam and propofol sedation
You may not qualify if:
- No informed consent
- ASA IV or 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)
Qadeer MA, Vargo JJ, Dumot JA, Lopez R, Trolli PA, Stevens T, Parsi MA, Sanaka MR, Zuccaro G. Capnographic monitoring of respiratory activity improves safety of sedation for endoscopic cholangiopancreatography and ultrasonography. Gastroenterology. 2009 May;136(5):1568-76; quiz 1819-20. doi: 10.1053/j.gastro.2009.02.004.
PMID: 19422079BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
- Capnography During Upper GI Endoscopy
Study Record Dates
First Submitted
November 16, 2010
First Posted
November 17, 2010
Study Start
June 1, 2010
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
November 22, 2011
Record last verified: 2010-11