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Capnographic Monitoring of Propofol-sedation During Colonoscopy

This study is currently recruiting participants.
Verified June 2012 by Johann Wolfgang Goethe University Hospitals
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01638793
First received: July 11, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted

July 11, 2012
July 11, 2012
June 2012
December 2013   (final data collection date for primary outcome measure)
Hypoxia (SO2 <90%) [ Designated as safety issue: Yes ]
Study objective is to evaluate if a reduction of hypoxic events (SO2 <90% for ≥ 15 sec) can be obtained with capnographic monitoring as compared to standard monitoring of respiration with pulse-oxymetry in patients receiving colonoscopy under Propofol-based sedation
Same as current
No Changes Posted
  • Severe Hypoxia (SO2 <85%) [ Designated as safety issue: Yes ]
    Evaluate events of severe hypoxia (SO2 < 85%) in group 1 (capnographic monitoring) as compared to group 2 (oxymetric monitoring)
  • Time to hypoxia [ Designated as safety issue: Yes ]
    Evaluate the time difference between abnormal ventilation shown on capnography machine and hypoxemia.
  • Hypoxia in relation to sedation [ Designated as safety issue: Yes ]
    Compare events of hypoxemia and severe hypoxemia during sedation with propofol only as compared to propofol/ketamin combination sedation.
  • Vegetative Symptoms [ Designated as safety issue: Yes ]
    Evaluate vegetative events (hypotension, hypertension, bradycardia, tachycardia, tachypnea, bradypnea) in both groups during the two sedation forms
Same as current
 
 
 
Capnographic Monitoring of Propofol-sedation During Colonoscopy
Capnographic Monitoring of Propofol-sedation During Colonoscopy

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.
 
Interventional
 
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Hypoxia
  • Device: Microcap (Oridion, Needham, MA, USA)
  • Device: Smart Capno Line Plus O2 (Oridion, Needham, MA, USA)
  • Experimental: Capnography
    Capnographic respiration monitoring
    Intervention: Device: Microcap (Oridion, Needham, MA, USA)
  • Active Comparator: Pulse-Oxymetry
    pulse-oxymetric respiration monitoring
    Intervention: Device: Smart Capno Line Plus O2 (Oridion, Needham, MA, USA)
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
528
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Mireen Friedrich-Rust, MD +49696301 ext 5122 Mireen.Friedrich-Rust@kgu.de
Germany
 
NCT01638793
JWGUHMED1-006
No
 
Johann Wolfgang Goethe University Hospitals
 
Principal Investigator: Mireen Friedrich-Rust, MD Klinikum der J. W. Goethe-Universität Frankfurt am Main
Johann Wolfgang Goethe University Hospitals
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP