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Status unknownNCT01242358PEGUpdated Nov 22, 2011

Capnography During Percutaneous Endoscopic Gastrostomy (PEG)

A Phase 3 interventional study of Capnography and Standard monitoring in In the Study the Value of Capnography for Avoiding Complications During Sedation for PEG is Evaluated., sponsored by Ruhr University of Bochum. Status unknown at 3 sites in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-11-22.

Sponsored by Ruhr University of Bochum · Phase 3, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Nov 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
170
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • hypoxaemia - capnography - integrated pulmonary index - PEG
03

In context

Lead sponsor

Ruhr University of Bochum is the lead sponsor of 124 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • No informed consent
  • ASA V
  • Emergency endoscopy
  • Preexisting hypotension, bradycardia or hypoxemia
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
170 participants (estimated)

Study arms

  • Experimental
    Capnography

    Arm with capnographic monitoring

    Device: Capnography

  • Placebo comparator
    Standard monitoring

    Standard monitoring

    Device: Standard monitoring

Interventions

  • DeviceCapnography

    Capnographic monitoring

  • DeviceStandard monitoring

    Standard monitoring

06

What researchers measure

Primary outcomes

  1. Hypoxemia

    Time frame: From the beginning to the end of the PEG procedure, i.e. from 0h to approximately 2h

Secondary outcomes

  1. Further complications

    Time frame: From the beginning to the end of the PEG procedure, i.e. from 0h to approximately 2h

07

Study locations

3 of 3 sites recruiting
  • Ruhr Universität Bochum
    Bochum, 44892, Germany
    • Andrea Riphaus, MD · Contact · ariphaus@web.de · +49-234-299
    • Andrea Riphaus, MD · Principal investigator
    Recruiting
  • Technische Universität München
    München, 81675, Germany
    • Stefan von Delius,, MD · Contact
    • Stefan von Delius, MD · Principal investigator
    Recruiting
  • Deutsche Klinik für Diagnostik
    Wiesbaden, 65191, Germany
    • Till Wehrmann, Prof. · Contact
    • Till Wehrmann, Prof. · Principal investigator
    Recruiting
08

References and documents

Publications

  • 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. Gastrointest Endosc. 2002 Jun;55(7):826-31. doi: 10.1067/mge.2002.124208. PubMed 12024135 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01242358
Lead sponsor
Ruhr University of Bochum
Responsible party
Andrea Riphaus (Clinical value of capnography During Percutaneous Endoscopic Gastrostomy (PEG), Ruhr University of Bochum) — Principal investigator
First posted
Nov 17, 2010
Start date
Jun 2010
Primary completion
Dec 2011 (estimated)
Completion
Mar 2012 (estimated)
Last update
Nov 22, 2011

Study contacts

Andrea Riphaus, MD
Contact
ariphaus@web.de
+49-234-299 ext. 80200
Andrea Riphaus, MD
principal investigator · Ruhr-Universität Bochum

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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