JMIR Publications

ABSTRACT

Background:

Drug-related deaths worldwide are most commonly attributed to opioids. Opioids and other sedative drugs can cause respiratory depression and airway compromise, leading to hypoxia and death. Device technology and artificial intelligence used to detect drug overdose has potential to improve outcomes. PneumoWave Ltd have developed a small chest-worn respiratory monitoring device to detect concerning breathing patterns and alert an emergency response.

Objective:

The aim of this study is to investigate the feasibility of use of the PneumoWave device in hospital patients at risk of respiratory depression.

Methods:

This 18-month prospective observational study is performed at the Queen Elizabeth University Hospital, Glasgow. The study investigates the use of the device on three groups of patients at risk of respiratory depression due to drugs. This includes patients attending the Emergency Department (ED) due to sedative drug overdose, patients receiving procedural sedation and analgesia in the ED, and patients receiving general anesthesia in theatres. Consenting participants will have the PneumoWave sensor monitoring paired with end-tidal CO2 and regular recordings of vital signs. Usability is tested by questionnaire of the patient, the clinician, and the nurse. The primary endpoint is to determine the feasibility of gathering respiratory data from a wearable respiratory monitoring device in the ED. Statistical analysis includes comparison of biosensor data against reference physiology time course data.

Results:

This study will examine the use of the PneumoWave device in a variety of patient situations in which risk of respiratory depression is present, providing valuable insight into the use of device technology in individuals at risk of illicit drug-related harm within the relative safety of a hospital setting. A limitation to study procedure is exclusion of patients with intoxication after sedative drug overdose who lack capacity to provide informed consent.

Conclusions:

This study has been designed to acquire foundation data to demonstrate the potential for continuous respiratory monitoring to improve outcomes for patients who are at risk of drug induced respiratory depression, inform product development, and inform design of future pivotal clinical investigations. Clinical Trial: The trial was registered on the 30th of March 2022 on clinicaltrials.gov, reference: NCT05358132.