Capnography During ERCP

Phase 3

Completed

• Conditions: Hypoxemia; Complications
• Interventions: Procedure: Capnography; Procedure: Standard monitoring

• Registration Number: NCT01072474
• Lead Sponsor: Technical University of Munich

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-18
• Study First Submitted QC: 2010-02-19
• Study First Posted: 2010-02-22
• Primary Completion: 2011-02
• Study Completion: 2012-03
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-23
• Last Update Posted: 2012-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Capnography	Capnography	Arm with capnographic monitoring
Standard	Standard monitoring	Standard monitoring.

Primary Outcome Measures

Name	Time	Method
Hypoxemia	From the beginning to the end of the ERCP procedure, i.e. from 0h to approximately 2h

Secondary Outcome Measures

Name	Time	Method
Further complications	From the beginning to the end of the ERCP procedure, i.e. from 0h to approximately 2h

Trial Locations

Locations (3)

Technische Universität München; 🇩🇪 Munich, Bavaria, Germany

Deutsche Klinik für Diagnostik; 🇩🇪 Wiesbaden, Germany

Knappschaftskrankenhaus der Ruhr-Universität Bochum; 🇩🇪 Bochum, Germany