Capnography During Percutaneous Endoscopic Gastrostomy (PEG)

Phase 3

• Conditions: In the Study the Value of Capnography for Avoiding Complications During Sedation for PEG is Evaluated.
• Interventions: Device: Capnography; Device: Standard monitoring

• Registration Number: NCT01242358
• Lead Sponsor: Ruhr University of Bochum

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-11-16
• Study First Submitted QC: 2010-11-16
• Study First Posted: 2010-11-17
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-20
• Last Update Posted: 2011-11-22
• Primary Completion: 2011-12
• Study Completion: 2012-03

Recruitment & Eligibility

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

Inclusion Criteria

• 18 Years and older
• Scheduled for PEG with propofol sedation

Exclusion Criteria

• No informed consent
• ASA 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
Standard monitoring	Standard monitoring	Standard monitoring

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Deutsche Klinik für Diagnostik; 🇩🇪 Wiesbaden, Germany

Ruhr Universität Bochum; 🇩🇪 Bochum, Germany

Technische Universität München; 🇩🇪 München, Germany