Status:
UNKNOWN
Development of an Algorithm That Predicts Hypoventilation Due to an Opioid Overdose
Lead Sponsor:
RTM Vital Signs, LLC
Collaborating Sponsors:
Thomas Jefferson University
Conditions:
Drug Overdose
Opioid-Related Disorders
Eligibility:
All Genders
18-40 years
Brief Summary
RTM Vital Signs, LLC is developing a miniature wearable tracheal sound sensor that communicates with a cell phone containing a machine-learning diagnostic algorithm designed to detect and predict the ...
Detailed Description
More than 64,000 Americans died from a drug overdose in 2016 and drug overdose is now the most common cause of death for people under 50 years old in the United States. The purpose of this study is to...
Eligibility Criteria
Inclusion
- Healthy women/men between 18 and 40 years of age.
- Negative history of drug or alcohol abuse.
- Negative history of cigarette smoking in previous 6 months.
- Negative history of active cardiac, vascular, pulmonary, renal, hepatic, nervous, metabolic or immune disease.
- BMI \< 30
Exclusion
- Age \< 18 years and \> 40 years.
- Pregnant or planning to become pregnant.
- Positive history drug or alcohol abuse.
- Positive drug screen for opioids, benzodiazepines, hypnotics.
- Positive Drug Abuse Screening Test result (score of 6 or greater).
- BMI \> 30
- History of sleep apnea.
- History of cigarette smoking in previous 6 months.
- History of difficult airway during anesthesia management.
- History of allergy or skin sensitivity to tape, silicone, fentanyl, chlorhexidine.
Key Trial Info
Start Date :
May 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 14 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03845699
Start Date
May 15 2019
End Date
May 14 2020
Last Update
May 9 2019
Active Locations (1)
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1
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107