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.

Study Overview

• Status: Completed
• Conditions: Hypoxia
• Intervention / Treatment: Device: Microcap (Oridion, Needham, MA, USA); Device: Smart Capno Line Plus O2 (Oridion, Needham, MA, USA)

• Study Type: Interventional
• Enrollment (Anticipated): 528
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Frankfurt am Main, Germany, 60590
    • Klinikum der J. W. Goethe-Universität
  • Frankfurt am Main, Germany, 60596
    • Praxisklinik am Staedel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Capnography; Capnographic respiration monitoring	Device: Microcap (Oridion, Needham, MA, USA)
Active Comparator: Pulse-Oxymetry; pulse-oxymetric respiration monitoring	Device: Smart Capno Line Plus O2 (Oridion, Needham, MA, USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description
Hypoxia (SO2 <90%)	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

Secondary Outcome Measures

Outcome Measure	Measure Description
Severe Hypoxia (SO2 <85%)	Evaluate events of severe hypoxia (SO2 < 85%) in group 1 (capnographic monitoring) as compared to group 2 (oxymetric monitoring)
Time to hypoxia	Evaluate the time difference between abnormal ventilation shown on capnography machine and hypoxemia.
Hypoxia in relation to sedation	Compare events of hypoxemia and severe hypoxemia during sedation with propofol only as compared to propofol/ketamin combination sedation.
Vegetative Symptoms	Evaluate vegetative events (hypotension, hypertension, bradycardia, tachycardia, tachypnea, bradypnea) in both groups during the two sedation forms

Collaborators and Investigators

• Sponsor: Johann Wolfgang Goethe University Hospital
• Investigators: Principal Investigator: Mireen Friedrich-Rust, MD, Klinikum der J. W. Goethe-Universität Frankfurt am Main

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: July 11, 2012
• First Submitted That Met QC Criteria: July 11, 2012
• First Posted (Estimate): July 12, 2012

Study Record Updates

• Last Update Posted (Estimate): October 25, 2013
• Last Update Submitted That Met QC Criteria: October 24, 2013
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: JWGUHMED1-006