Clinical trial NCT05358132: ARM-ED: Advanced Respiratory Monitoring Events in Drug Toxicity
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Insufficiency
Overdose of Opiate
Sedative Overdose
Sedative Toxicity
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: Pneumowave Ltd
First posted: 2022-05-03
Enrollment: 78
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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. All patients who fit the below criteria will be potential candidates for the study. They study team will confirm their eligibility and then they will be included.

Group 1 - Acute toxicity group screening: any patient presenting to the Queen Elizabeth University Hospital (QEUH) ED with overdose of sedating drug.

Group 2 - PSA group screening: and patient undergoing PSA in at QEUH ED

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Length of time device in situ on patient
timeFrame: 1 year
measure: Number of times device removed by patient / other
timeFrame: 1 year
measure: Proportion of waveform data collected while in situ
timeFrame: 1 year
Secondary outcomes:
measure: Observation of waveform data from Pneumowave device
timeFrame: Duration of study period, up to 15 months
measure: Compare Pneumowave respiratory wave patterns to clinical events
timeFrame: Duration of study period, up to 15 months
measure: Compare respiratory waveform patterns and motion artefact data
timeFrame: Duration of study period, up to 15 months
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Emergency Department, Queen Elizabeth University Hospital
Study officials:
affiliation: NHS Greater Glasgow and Clyde
name: David J Lowe, MBChB BMSc FRCEM
role: PRINCIPAL_INVESTIGATOR
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