Capnography During Percutaneous Endoscopic Gastrostomy (PEG)

NCT ID: NCT01242358

Last Updated: 2011-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-03-31

Brief Summary

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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

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Conditions

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

Keywords

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hypoxaemia - capnography - integrated pulmonary index - PEG

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Capnography

Arm with capnographic monitoring

Group Type EXPERIMENTAL

Capnography

Intervention Type DEVICE

Capnographic monitoring

Standard monitoring

Standard monitoring

Group Type PLACEBO_COMPARATOR

Standard monitoring

Intervention Type DEVICE

Standard monitoring

Interventions

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Capnography

Capnographic monitoring

Intervention Type DEVICE

Standard monitoring

Standard monitoring

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ruhr University of Bochum

OTHER

Sponsor Role lead

Responsible Party

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Andrea Riphaus

Clinical value of capnography During Percutaneous Endoscopic Gastrostomy (PEG)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Riphaus, MD

Role: PRINCIPAL_INVESTIGATOR

Ruhr-Universität Bochum

Locations

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Ruhr Universität Bochum

Bochum, , Germany

Site Status RECRUITING

Technische Universität München

München, , Germany

Site Status RECRUITING

Deutsche Klinik für Diagnostik

Wiesbaden, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Andrea Riphaus, MD

Role: CONTACT

Phone: +49-234-299

Email: [email protected]

Facility Contacts

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Andrea Riphaus, MD

Role: primary

Stefan von Delius,, MD

Role: primary

Till Wehrmann, Prof.

Role: primary

References

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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.

Reference Type RESULT
PMID: 12024135 (View on PubMed)

Other Identifiers

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Capno-PEG 2010

Identifier Type: -

Identifier Source: org_study_id