ARM-ED: Advanced Respiratory Monitoring Events in Drug Toxicity

Study Overview
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Brief Summary
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There is a drug-related death crisis in Scotland. The majority of these deaths have involved the misuse of opiates (e.g. heroin) and benzodiazepines (e.g. valium) which cause an individual to stop breathing. The Advanced Respiratory Monitoring Events in Drug Toxicity (ARM-ED) study is a study investigating whether a wearable sensor can help detect problems with breathing in patients who have had drugs or medications that may cause this effect. The study will span a year and will study two groups of patients - those who attend with actual or expected respiratory depression secondary to acute drug toxicity and individuals who have undergone procedural sedation and analgaesia in the Emergency Department.

Detailed Description
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This study aims to assess if it is feasible to collect respiratory waveform data using an advanced respiratory monitoring device named Pneumowave and whether the device is user friendly in terms of nurse, clinician, and patient. This is an observational cohort study which utilises passive non-invasive data collection. The device, Pneumowave, will be studied in two distinct groups of patients: those who attend with actual or expected respiratory depression secondary to acute drug toxicity (Group 1) and individuals who have undergone procedural sedation and analgaesia (PSA) in the ED (Group 2). Participants will be studied for the duration of their ED attendance or in the case of PSA for the duration of their sedation and recovery period. They will be followed up via electronic notes 28 days later to identify adverse outcome and to link cases to available toxicology screens performed. The target number of participants in this study is 100. 50 patients who fit group 1 characteristics and 50 patients who fit group 2 characteristics. Data from Pneumowave will be analysed in parallel with de-identified clinical and vital sign observational data to inform artificial intelligence driven predictive modelling algorithms. This study will inform on the utilisation and usability of a wearable device for monitoring an individual's respiratory patterns following the effects of sedative drug use. It will add understanding to potential use of such a device to predict the respiratory compromise in the wearer and alert appropriate stakeholders for timely intervention and ultimately prevention of the wearer's morbidity and mortality.

Official Title
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ARM-ED: Advanced Respiratory Monitoring Events in Drug Toxicity - An Emergency Department Feasibility Study of the Utilisation of a Wearable Device in Patients With Sedative Effects of Drugs

Conditions
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Respiratory Insufficiency, Overdose of Opiate, Sedative Overdose, Sedative Toxicity

Intervention / Treatment
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* Device: Pneumowave Device placement and data capture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Group 1 - Acute toxicity group Presentation to ED due to presumed overdose of drug with potential for respiratory depression (intentional, accidental, recreational, therapeutic excess) At least one of GCS <15 or respiratory depression or risk of deterioration of GCS or respiration. Age >16 years Are willing and able to give informed consent or have available next of Kin to provide informed consent on the participant's behalf Able (in the Investigators opinion) and willing to comply with all study requirements Group 2 - PSA group Patient undergoing procedural sedation and anaesthesia in ED Age >16 years Are willing and able to give informed consent Able (in the Investigators opinion) and willing to comply with all study requirements Can speak and read English Exclusion Criteria: Group 1 - Acute toxicity group Unable to provide consent and no next of kin to provide consent on participant's behalf Impaired consciousness / respiratory suppression most likely due to cause other than acute drug use Condition primarily related to alcohol use and no evidence of acute drug use Condition due to withdrawal of drugs / alcohol. Treating clinician deems patient inappropriate to be included in study Group 2 - PSA group Unable to provide consent Treating clinician deems patient inappropriate to be included in study

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ARM-ED group 1 - Acute toxicity group<br>Patients attending the Emergency Department with acute sedating drug toxicity | Device: Pneumowave Device placement and data capture<br>* Participants in the acute toxicity group will be studied for a period of time during their Emergency Department attendance or in the case of PSA for the duration of their sedation and recovery period. Usual care will be provided to the patient with additional period with Pneumowave biosensor placed onto chest and data capture for a period of time whilst patient is in the Emergency Department,<br>|
| ARM-ED group 2 - PSA group<br>Patients undergoing procedural sedation and analgaesia in the Emergency Department | Device: Pneumowave Device placement and data capture<br>* Participants in the acute toxicity group will be studied for a period of time during their Emergency Department attendance or in the case of PSA for the duration of their sedation and recovery period. Usual care will be provided to the patient with additional period with Pneumowave biosensor placed onto chest and data capture for a period of time whilst patient is in the Emergency Department,<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of time device in situ on patient | Absolute length of time device in situ on patient and as proportion of intended length of time of device data capture. | 1 year | 
| Number of times device removed by patient / other | Number of times device removed total during each study episode. | 1 year | 
| Proportion of waveform data collected while in situ | Length in time of waveform data collection as proportion of intended length of time of device data capture. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observation of waveform data from Pneumowave device | Observation of waveform data from Pneumowave device and compare to: Normal care vital signs Continuous monitoring vital signs extracted from patient monitors | Duration of study period, up to 15 months | 
| Compare Pneumowave respiratory wave patterns to clinical events | Compare Pneumowave respiratory wave patterns to clinical events: Normal respiratory patterns Clinical deterioration Interventions in ED | Duration of study period, up to 15 months | 
| Compare respiratory waveform patterns and motion artefact data | Compare respiratory waveform patterns and motion artefact data to: GCS Richmond Agitation-Sedation Scale (RASS) | Duration of study period, up to 15 months |