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Testing of the Apnea Prevention Device

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2009 by Oregon Health and Science University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00875134
First Posted: April 3, 2009
Last Update Posted: April 3, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Oregon Health and Science University
April 2, 2009
April 3, 2009
April 3, 2009
March 2009
December 2009   (Final data collection date for primary outcome measure)
Efficacy in treating respiratory depression [ Time Frame: seconds after desaturation ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Testing of the Apnea Prevention Device
Testing of the Apnea Prevention Device
This study is designed to test the ability of a computer-based algorithm to detect and intervene in cases of narcotic-induced respiratory depression.
Not Provided
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Respiratory Depression
  • Elective Surgery
  • Other: Verbal prompt
    Patient hears a voice recording
  • Other: Skin Stimulus
    Patient receives either a skin stimulus
Experimental: Verbal prompt, cutaneous stimulation
Patient receives either or both a verbal stimulus or cutaneous stimulus
Interventions:
  • Other: Verbal prompt
  • Other: Skin Stimulus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
35
December 2009
December 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Elective surgical patients

Exclusion Criteria:

  • Refusal to consent to study
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00875134
10-06-54
No
Not Provided
Not Provided
Mark Zornow, MD, OHSU
Oregon Health and Science University
Not Provided
Not Provided
Oregon Health and Science University
April 2009

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