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Capnographic Monitoring of Propofol-sedation During Colonoscopy

NCT ID: NCT01638793

Last Updated: 2013-10-25

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

NA

Total Enrollment

528 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-09-30

Brief Summary

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The present study is a randomized, prospective, single-blinded study. Patients presenting for colonoscopy under sedation will be included according to the statistical sample size calculation. Patients will be randomized to either group 1- capnographic monitoring or group 2- oxygenic monitoring during Propofol-based sedation for colonoscopy. Episodes of Hypoxia are documented and compared in both groups.

Detailed Description

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Conditions

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Hypoxia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Capnography

Capnographic respiration monitoring

Group Type EXPERIMENTAL

Microcap (Oridion, Needham, MA, USA)

Intervention Type DEVICE

Pulse-Oxymetry

pulse-oxymetric respiration monitoring

Group Type ACTIVE_COMPARATOR

Smart Capno Line Plus O2 (Oridion, Needham, MA, USA)

Intervention Type DEVICE

Interventions

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Microcap (Oridion, Needham, MA, USA)

Intervention Type DEVICE

Smart Capno Line Plus O2 (Oridion, Needham, MA, USA)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Indication for colonoscopy
* Patient wishing sedation during colonoscopy
* ≥ 18 years of age
* Signed informed consent form

Exclusion Criteria

* Diseases which preclude study accomplishment or put the patient at any risk (e.g. psychiatric diseases)
* Non-contractually capable persons
* Pregnancy
* Lactation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Mireen Friedrich-Rust, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum der J. W. Goethe-Universität Frankfurt am Main

Locations

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Klinikum der J. W. Goethe-Universität

Frankfurt am Main, , Germany

Site Status

Praxisklinik am Staedel

Frankfurt am Main, , Germany

Site Status

Countries

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Germany

Other Identifiers

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JWGUHMED1-006

Identifier Type: -

Identifier Source: org_study_id