Capnography During Upper GI Endoscopy

NCT ID: NCT01242345

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-11-30

Brief Summary

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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

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Conditions

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Capnography as an Adjunct to Standard Monitoring During Midazolam and Propofol Sedation for Interventional Upper GI Endoscopy

Keywords

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Hypoxemia Capnography Integrated pulmonary index Sedation Propofol Safety

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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No Intervention

Standard monitoring.

Group Type NO_INTERVENTION

No interventions assigned to this group

Capnography

Arm with capnographic monitoring

Group Type EXPERIMENTAL

Capnography

Intervention Type DEVICE

Monitoring of the capnography curve for early detection of apnea

Interventions

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Capnography

Monitoring of the capnography curve for early detection of apnea

Intervention Type DEVICE

Eligibility Criteria

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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
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

Capnography During Upper GI Endoscopy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ruhr Universität Bochum

Bochum, , Germany

Site Status

Technische Universität München

München, , Germany

Site Status

Deutsche Klinik für Diagnostik

Wiesbaden, , Germany

Site Status

Countries

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Germany

References

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Qadeer MA, Vargo JJ, Dumot JA, Lopez R, Trolli PA, Stevens T, Parsi MA, Sanaka MR, Zuccaro G. Capnographic monitoring of respiratory activity improves safety of sedation for endoscopic cholangiopancreatography and ultrasonography. Gastroenterology. 2009 May;136(5):1568-76; quiz 1819-20. doi: 10.1053/j.gastro.2009.02.004.

Reference Type BACKGROUND
PMID: 19422079 (View on PubMed)

Other Identifiers

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Capno-Interventional 2011

Identifier Type: -

Identifier Source: org_study_id