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Testing of the Apnea Prevention Device

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ClinicalTrials.gov Identifier: NCT00875134
Recruitment Status : Unknown
Verified April 2009 by Oregon Health and Science University.
Recruitment status was:  Active, not recruiting
First Posted : April 3, 2009
Last Update Posted : April 3, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Respiratory Depression Elective Surgery Other: Verbal prompt Other: Skin Stimulus Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Testing of the Apnea Prevention Device
Study Start Date : March 2009
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

Eligibility Criteria

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 Posted: April 3, 2009    Key Record Dates
Last Update Posted: April 3, 2009
Last Verified: April 2009

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