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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
  Purpose
This study is designed to test the ability of a computer-based algorithm to detect and intervene in cases of narcotic-induced respiratory depression.

Condition Intervention Phase
Respiratory Depression Elective Surgery Other: Verbal prompt Other: Skin Stimulus Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Testing of the Apnea Prevention Device

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Efficacy in treating respiratory depression [ Time Frame: seconds after desaturation ]

Estimated Enrollment: 35
Study Start Date: March 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Verbal prompt, cutaneous stimulation
Patient receives either or both a verbal stimulus or cutaneous stimulus
Other: Verbal prompt
Patient hears a voice recording
Other: Skin Stimulus
Patient receives either a skin stimulus

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective surgical patients

Exclusion Criteria:

  • Refusal to consent to study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00875134


Locations
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
  More Information

Responsible Party: Mark Zornow, MD, OHSU
ClinicalTrials.gov Identifier: NCT00875134     History of Changes
Other Study ID Numbers: 10-06-54
First Submitted: April 2, 2009
First Posted: April 3, 2009
Last Update Posted: April 3, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases