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Testing of the Apnea Prevention Device

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ClinicalTrials.gov Identifier: NCT00875134
Recruitment Status : Completed
First Posted : April 3, 2009
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Mark H. Zornow, Oregon Health and Science University

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 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
Actual Primary Completion Date : October 2009
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine


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




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


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

Inclusion Criteria:

  • Elective surgical patients

Exclusion Criteria:

  • Refusal to consent to study

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

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Responsible Party: Mark H. Zornow, Principal Investigator, Oregon Health and Science University
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: June 18, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases