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Completed

NCT Number: NCT05358132

ARM-ED: Advanced Respiratory Monitoring Events in Drug Toxicity

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Emergency Department, Queen Elizabeth University Hospital

Glasgow, G51 4FT, United Kingdom

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pneumowave Device placement and data capture

Device

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,

Primary outcomes

  1. Length of time device in situ on patient

    Time frame: 1 year

    Absolute length of time device in situ on patient and as proportion of intended length of time of device data capture.

  2. Number of times device removed by patient / other

    Time frame: 1 year

    Number of times device removed total during each study episode.

  3. Proportion of waveform data collected while in situ

    Time frame: 1 year

    Length in time of waveform data collection as proportion of intended length of time of device data capture.

Secondary outcomes

  1. Observation of waveform data from Pneumowave device

    Time frame: Duration of study period, up to 15 months

    Observation of waveform data from Pneumowave device and compare to:

    • Normal care vital signs
    • Continuous monitoring vital signs extracted from patient monitors
  2. Compare Pneumowave respiratory wave patterns to clinical events

    Time frame: Duration of study period, up to 15 months

    Compare Pneumowave respiratory wave patterns to clinical events:

    • Normal respiratory patterns
    • Clinical deterioration
    • Interventions in ED
  3. Compare respiratory waveform patterns and motion artefact data

    Time frame: Duration of study period, up to 15 months

    Compare respiratory waveform patterns and motion artefact data to:

    • GCS
    • Richmond Agitation-Sedation Scale (RASS)

Sponsors and collaborators

Lead sponsor

NHS Greater Glasgow and Clyde

Other

Collaborators

  • Pneumowave Ltd

Registry information

Official study 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

Acronym: ARM-ED

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 3, 2022
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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