Feasibility Trial for Detecting Drug-induced Respiratory Depression and Prompting for Self-rescue

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: Prompting breaths via recorded voice, vibrating massager, and/or muscle tetany

• Registration Number: NCT02744599
• Lead Sponsor: University of Utah

Brief Summary

This is a small trial to test feasibility of an idea for a potential device. The investigators tested the feasibility of prompting a volunteer to breathe when their breathing had slowed down during administration of anesthetic drugs.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2013-10
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Study First Submitted: 2016-04-07
• Study First Submitted QC: 2016-04-19
• Study First Posted: 2016-04-20
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-13
• Last Update Posted: 2019-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• American Society of Anesthesia (ASA) Class I and Class II male and female (non-pregnant/non-lactating) volunteers.
• Normal healthy individual as indicated by medical history and a physical examination.
• At least 18 years of age and less than 55 years of age.
• Negative drug screen.
• Uncomplicated airway anatomy.
• A Body Mass Index between 18 and 32.
• Are fully informed of the risks of entering the study and willingly provide written consent to enter the trial.
• Female subjects of child bearing potential will have a negative urine pregnancy test on the day the study is conducted.

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Exclusion Criteria

• Known or suspected neurological pathologies.
• A history of significant alcohol or drug abuse, a history of allergy to opioids or propofol, or a history of chronic drug requirement or medical illness that is known to alter the pharmacokinetics or pharmacodynamics of remifentanil and propofol.
• Known obstructive sleep apnea.
• Known or suspected hypersensitivity to any compound present in the study.
• Any potential subject suffering from medical problems that, in the judgment of the investigator, presents unacceptable risk to the volunteer are not eligible for enrollment.
• Vulnerable subject groups such as prisoners and the mentally disabled that are traditionally excluded from medical research are also excluded.
• The potential subject has taken any medication within 2 days prior to chosen drug administration, with the exception of oral contraceptives.
• The potential subject is wearing artificial nails.
• A positive urine pregnancy test (females only)
• Female subjects who are currently lactating & breast-feeding.
• A positive drug-screening test.
• The subject consumed food or fluids within 8 hours prior to start of each chosen drug administration.
• Any medications or alcohol within 2 days prior to start of the chosen drug administration, with the exception of oral contraceptives.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Device prompting	Prompting breaths via recorded voice, vibrating massager, and/or muscle tetany	-

Primary Outcome Measures

Name	Time	Method
Breath prompting successful rate	Change in respiratory rate from baseline to the period 10 seconds after the breath prompt