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Testing of the Apnea Prevention Device

Primary Purpose

Respiratory Depression, Elective Surgery

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Verbal prompt
Skin Stimulus
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Depression

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Elective surgical patients

Exclusion Criteria:

  • Refusal to consent to study

Sites / Locations

  • Oregon Health and Science University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Verbal prompt, cutaneous stimulation

Arm Description

Patient receives either or both a verbal stimulus or cutaneous stimulus

Outcomes

Primary Outcome Measures

Efficacy in treating respiratory depression

Secondary Outcome Measures

Full Information

First Posted
April 2, 2009
Last Updated
June 14, 2019
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT00875134
Brief Title
Testing of the Apnea Prevention Device
Official Title
Testing of the Apnea Prevention Device
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Depression, Elective Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Verbal prompt, cutaneous stimulation
Arm Type
Experimental
Arm Description
Patient receives either or both a verbal stimulus or cutaneous stimulus
Intervention Type
Other
Intervention Name(s)
Verbal prompt
Intervention Description
Patient hears a voice recording
Intervention Type
Other
Intervention Name(s)
Skin Stimulus
Intervention Description
Patient receives either a skin stimulus
Primary Outcome Measure Information:
Title
Efficacy in treating respiratory depression
Time Frame
seconds after desaturation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Elective surgical patients Exclusion Criteria: Refusal to consent to study
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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Testing of the Apnea Prevention Device

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