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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Device prompting

Group Type EXPERIMENTAL

Prompting breaths via recorded voice, vibrating massager, and/or muscle tetany

Intervention Type DEVICE

Prompt volunteer to breathe using device to play recorded voice, massage the body, and/or apply muscle tetany

Control

Patients receive standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Prompting breaths via recorded voice, vibrating massager, and/or muscle tetany

Prompt volunteer to breathe using device to play recorded voice, massage the body, and/or apply muscle tetany

Intervention Type DEVICE

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes