Healthy
Conditions
Keywords
Feasibility trial
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.
Interventions
DEVICEPrompting 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
Sponsors
National Institute of Nursing Research (NINR)
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Breath prompting successful rate | Change in respiratory rate from baseline to the period 10 seconds after the breath prompt |
Outcome results
None listed