Capnography During Percutaneous Endoscopic Gastrostomy (PEG)

In the Study the Value of Capnography for Avoiding Complications During Sedation for PEG is Evaluated. Clinical Trial

— PEG  

Official title:

Clinical Value of Advanced Patient Monitoring Using Capnography With Analysis of the Integrated Pulmonary Index During Percutaneous Endoscopic Gastrostomy.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01242358
• Other study ID #: Capno-PEG 2010
• Status: Recruiting
• Phase: Phase 3
• First received: November 16, 2010
• Last updated: November 20, 2011
• Start date: June 2010
• Est. completion date: March 2012

Study information

• Verified date: November 2011
• Source: Ruhr University of Bochum
• Contact: Andrea Riphaus, MD
• Phone: +49-234-299
• Email: ariphaus[@]web.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• In the Study the Value of Capnography for Avoiding Complications During Sedation for PEG is Evaluated.

Intervention

Device:
• Capnography
Capnographic monitoring
• Standard monitoring
Standard monitoring

Locations

Country	Name	City	State
Germany	Ruhr Universität Bochum	Bochum
Germany	Technische Universität München	München
Germany	Deutsche Klinik für Diagnostik	Wiesbaden

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Vargo JJ, Zuccaro G Jr, Dumot JA, Conwell DL, Morrow JB, Shay SS. Automated graphic assessment of respiratory activity is superior to pulse oximetry and visual assessment for the detection of early respiratory depression during therapeutic upper endoscopy — View Citation

Outcome

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