ARM-ED: Advanced Respiratory Monitoring Events in Drug Toxicity (ARM-ED)

July 12, 2023 updated by: NHS Greater Glasgow and Clyde

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom, G51 4FT
        • Recruiting
        • Emergency Department, Queen Elizabeth University Hospital
        • Contact:
        • Principal Investigator:
          • David J Lowe, MBChB BMSc FRCEM
        • Principal Investigator:
          • Lisa C Dunlop, MBChB, BSc (hons), FRCEM
        • Sub-Investigator:
          • Chris Carlin
        • Sub-Investigator:
          • Fraser Denny, MBChB, FRCEM
        • Sub-Investigator:
          • Robert Docking
        • Sub-Investigator:
          • Bruce Henderson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ARM-ED group 1 - Acute toxicity group
Patients attending the Emergency Department with acute sedating drug toxicity
Device: Pneumowave Device placement and data capture

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,
ARM-ED group 2 - PSA group
Patients undergoing procedural sedation and analgaesia in the Emergency Department
Device: Pneumowave Device placement and data capture

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,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year
Number of times device removed by patient / other
Time Frame: 1 year
Number of times device removed total during each study episode.
1 year
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Duration of study period, up to 15 months
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
Duration of study period, up to 15 months
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)
Duration of study period, up to 15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Greater Glasgow and Clyde

Collaborators

Pneumowave Ltd

Investigators

  • Principal Investigator: David J Lowe, MBChB BMSc FRCEM, NHS Greater Glasgow and Clyde

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2022

Primary Completion (Estimated)

December 7, 2023

Study Completion (Estimated)

March 7, 2024

Study Registration Dates

First Submitted

March 30, 2022

First Submitted That Met QC Criteria

April 27, 2022

First Posted (Actual)

May 3, 2022

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INGN21RM077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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