Development of an Algorithm That Predicts Hypoventilation Due to an Opioid Overdose (NCT03845699) | Clinical Trial Compass
UnknownNot Applicable
Development of an Algorithm That Predicts Hypoventilation Due to an Opioid Overdose
United States20 participantsStarted 2019-05-15
Plain-language 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 onset of mild, moderate, and severe hypoventilation (respiratory depression) due to an opioid overdose. The purpose of this clinical trial is to develop/validate diagnostic algorithms capable of detecting/predicting the onset of hypoventilation induced by a controlled intravenous infusion of fentanyl. The wearable sensor and algorithms will provide a series of alerts and alarms to the person, caregiver, and/or emergency personnel.
Who can participate
Age range18 Years – 40 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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
What they're measuring
1
Percent Sensitivity and Specificity of Detecting/Predicting the Onset of Mild Hypoventilation due to an Opioid Overdose
Timeframe: 1 to 3 hours
2
Percent Sensitivity and Specificity of Detecting/Predicting the Onset of Moderate Hypoventilation due to an Opioid Overdose
Timeframe: 1 to 3 hours
3
Percent Sensitivity and Specificity of Detecting/Predicting the Onset of Severe Hypoventilation due to an Opioid Overdose