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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
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective surgical patients

Exclusion Criteria:

  • Refusal to consent to study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mark Zornow, MD, OHSU
ClinicalTrials.gov Identifier: NCT00875134     History of Changes
Other Study ID Numbers: 10-06-54
Study First Received: April 2, 2009
Last Updated: April 2, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Respiratory Insufficiency
Behavioral Symptoms
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 25, 2014