Capnography During Upper GI Endoscopy

Phase 3

Completed

• Conditions: Capnography as an Adjunct to Standard Monitoring During Midazolam and Propofol Sedation for Interventional Upper GI Endoscopy
• Interventions: Device: Capnography

• Registration Number: NCT01242345
• Lead Sponsor: Ruhr University of Bochum

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Status Verified: 2010-11
• Study First Submitted: 2010-11-16
• Study First Submitted QC: 2010-11-16
• Study First Posted: 2010-11-17
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Last Update Submitted: 2011-11-20
• Last Update Posted: 2011-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

• Age>=18
• Scheduled for interventional upper GI endoscopy with midazolam and propofol sedation

Exclusion Criteria

• No informed consent
• ASA IV or V
• Emergency endoscopy
• Preexisting hypotension, bradycardia or hypoxemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Capnography	Capnography	Arm with capnographic monitoring

Primary Outcome Measures

Name	Time	Method
Hypoxemia	From the start to the end of endoscopy, i.e. from 0 h to approximately 2 h

Secondary Outcome Measures

Name	Time	Method
Further complications	From the start to the end of endoscopy, i.e. from 0 h to approximately 2 h

Trial Locations

Locations (3)

Ruhr Universität Bochum; 🇩🇪 Bochum, Germany

Technische Universität München; 🇩🇪 München, Germany

Deutsche Klinik für Diagnostik; 🇩🇪 Wiesbaden, Germany