Utilization and Feasibility of a Wearable Device in Patients With Sedative Effects of Drugs: Protocol for a Prospective Observational Study for the Advanced Respiratory Monitoring Events in Drug Toxicity (ARM-ED) Study.

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 the potential to improve outcomes. PneumoWave Ltd has 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 using the PneumoWave device in hospital patients at risk of respiratory depression. Methods: This 18-month prospective observational study was performed at the Queen Elizabeth University Hospital, Glasgow. The study investigates the use of the device on 3 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 theaters. Consenting participants will have the PneumoWave sensor paired with end-tidal CO2 monitoring and regular recordings of vital signs. Usability will be tested by administering a questionnaire to the patient, the clinician, and the nurse. The primary end point 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: Trial recruitment was completed on December 8, 2023. Twenty-five patients were enrolled in group 1 (acute toxicity); 39 patients in group 2 (procedural sedation), including 1 patient who was subsequently withdrawn; and 14 patients in group 3 (acute toxicity), with 2 patients withdrawn. Publication of the study results is anticipated by December 2025. Conclusions: This study will explore the feasibility of the PneumoWave device in a variety of clinical contexts in which risk of pharmacologically induced respiratory depression is present. This will provide 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 of the study procedure is exclusion of patients with intoxication after sedative drug overdose who lack the capacity to provide informed consent. This study has been designed to acquire feasibility 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 the design of future pivotal clinical investigations.