NCT00875134

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 3, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

June 18, 2019

Status Verified

June 1, 2019

Enrollment Period

7 months

First QC Date

April 2, 2009

Last Update Submit

June 14, 2019

Conditions

Respiratory DepressionElective Surgery

Outcome Measures

Primary Outcomes (1)

  • Efficacy in treating respiratory depression

    seconds after desaturation

Study Arms (1)

Verbal prompt, cutaneous stimulation

EXPERIMENTAL

Patient receives either or both a verbal stimulus or cutaneous stimulus

Other: Verbal promptOther: Skin Stimulus

Interventions

Verbal promptOTHER

Patient hears a voice recording

Verbal prompt, cutaneous stimulation
Skin StimulusOTHER

Patient receives either a skin stimulus

Verbal prompt, cutaneous stimulation

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective surgical patients

You may not qualify if:

  • Refusal to consent to study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 2, 2009

First Posted

April 3, 2009

Study Start

March 1, 2009

Primary Completion

October 1, 2009

Study Completion

March 1, 2010

Last Updated

June 18, 2019

Record last verified: 2019-06

Locations

US(1)