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NCT01072474 Clinical Trial

Capnography During ERCP

Hypoxemia Clinical Trial

— EndoBreath  

Official title:
Capnography as an Adjunct to Standard Monitoring During Midazolam and Propofol Sedation for ERCP

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01072474
Other study ID # 2680/10
Secondary ID
Status Completed
Phase Phase 3
First received February 18, 2010
Last updated August 23, 2012
Start date February 2010
Est. completion date March 2012

Study information
Verified date August 2012
Source Technische Universität München
Contact n/a
Is FDA regulated No
Health authority Germany: Ethikkommission der Fakultät für Medizin der Technischen Universität München
Study type Interventional

Clinical Trial Summary

In the study the value of capnography for avoiding complications during sedation for ERCP is evaluated.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 242
Est. completion date March 2012
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age>=18

- Scheduled for colonoscopy with midazolam and propofol sedation

Exclusion Criteria:

- No informed consent

- ASA V

- Pregnancy

- Prexisting hypotension, bradycardia or hypoxemia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• Capnography
Capnographic monitoring
• Standard monitoring
Standard monitoring

Locations
Country Name City State
Germany Knappschaftskrankenhaus der Ruhr-Universität Bochum Bochum
Germany Technische Universität München Munich Bavaria
Germany Deutsche Klinik für Diagnostik Wiesbaden

Sponsors (1)
Lead Sponsor Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Hypoxemia From the beginning to the end of the ERCP procedure, i.e. from 0h to approximately 2h Yes
Secondary Further complications From the beginning to the end of the ERCP procedure, i.e. from 0h to approximately 2h Yes
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