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OpenTrials
Completed

NCT Number: NCT01072474

Capnography During ERCP

In the study the value of capnography for avoiding complications during sedation for ERCP is evaluated.

Completed

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Key information

Conditions

Hypoxemia Complications Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Technische Universität München, Munich, Bavaria, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age>=18
  • Scheduled for colonoscopy with midazolam and propofol sedation

Exclusion criteria

  • No informed consent
  • ASA V
  • Pregnancy
  • Prexisting hypotension, bradycardia or hypoxemia

Treatment and study plan

Capnography

Procedure

Capnographic monitoring

Standard Monitoring

Procedure

Standard monitoring

Primary outcomes

  1. Hypoxemia

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

Secondary outcomes

  1. Further complications

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

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

Capnography as an Adjunct to Standard Monitoring During Midazolam and Propofol Sedation for ERCP

Acronym: EndoBreath

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Feb 22, 2010
Registry last updated
Aug 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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