Clinical Trial

Predicting Hypoventilation Due to an Opioid Overdose

Study Description

Development of an Algorithm That Predicts Hypoventilation Due to an Opioid Overdose

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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Device - Diagnostic algorithms that detects/predicts hypoventilation

Produce mild and moderate respiratory depression (hypoventilation) using a controlled intravenous infusion of fentanyl while measuring/recording respiratory rate, tidal volume, body activity, and body position.

Additional Information

Official Study Title

Development of an Algorithm That Predicts Hypoventilation Due to an Opioid Overdose

Clinical Trial ID

NCT03845699

ParticipAid ID

b82z2e