Testing of the Apnea Prevention Device

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Oregon Health and Science University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00875134
First received: April 2, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted

April 2, 2009
April 2, 2009
March 2009
December 2009   (final data collection date for primary outcome measure)
Efficacy in treating respiratory depression [ Time Frame: seconds after desaturation ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Active, not recruiting
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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00875134
10-06-54
No
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