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

Study Overview
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Device: Prompting breaths via recorded voice, vibrating massager, and/or muscle tetany


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device prompting<br> | Device: Prompting breaths via recorded voice, vibrating massager, and/or muscle tetany<br>* Prompt volunteer to breathe using device to play recorded voice, massage the body, and/or apply muscle tetany<br>|
| No Intervention: Control<br>Patients receive standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breath prompting successful rate |  | Change in respiratory rate from baseline to the period 10 seconds after the breath prompt | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Feasibility trial