Overview

This trial is active, not recruiting.

Conditions respiratory depression, elective surgery
Treatments verbal prompt, skin stimulus
Phase phase 1/phase 2
Sponsor Oregon Health and Science University
Start date March 2009
End date December 2009
Trial size 35 participants
Trial identifier NCT00875134, 10-06-54

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Patient receives either or both a verbal stimulus or cutaneous stimulus
verbal prompt
Patient hears a voice recording
skin stimulus
Patient receives either a skin stimulus

Primary Outcomes

Measure
Efficacy in treating respiratory depression
time frame: seconds after desaturation

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: - Elective surgical patients Exclusion Criteria: - Refusal to consent to study

Additional Information

Official title Testing of the Apnea Prevention Device
Trial information was received from ClinicalTrials.gov and was last updated in April 2009.
Information provided to ClinicalTrials.gov by Oregon Health and Science University.