ARM-ED: Advanced Respiratory Monitoring Events in Drug Toxicity

NCT05358132 | Completed FDA Device

• 1 other identifier: INGN21RM077
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Insufficiency; Overdose of Opiate; Sedative Overdose; Sedative Toxicity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Observation of waveform data from Pneumowave device

  Duration of study period, up to 15 months

• Compare Pneumowave respiratory wave patterns to clinical events

  Duration of study period, up to 15 months

• Compare respiratory waveform patterns and motion artefact data

  Duration of study period, up to 15 months

Study Arms (2)

ARM-ED group 1 - Acute toxicity group

Patients attending the Emergency Department with acute sedating drug toxicity

Device: Pneumowave Device placement and data capture

ARM-ED group 2 - PSA group

Patients undergoing procedural sedation and analgaesia in the Emergency Department

Device: Pneumowave Device placement and data capture

Interventions

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,

ARM-ED group 1 - Acute toxicity group; ARM-ED group 2 - PSA group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• Pneumowave Ltd: collaborator

Study Sites (1)

Emergency Department, Queen Elizabeth University Hospital

Glasgow, G51 4FT, United Kingdom

Location

Related Publications (18)

• EMCDDA. Drug-related deaths and mortality in Europe. Update from EMCDDA expert network July 2019. Available from https://www.emcdda.europa.eu, accessed 09/02/2020

  BACKGROUND

• National records of Scotland, National Statistics. Drug-related deaths in Scotland in 2019, published 15/12/2020. Available from https://www.nrscotland.gov.uk/, accessed 09/02/2020.

  BACKGROUND

• Holland KM, Jones C, Vivolo-Kantor AM, Idaikkadar N, Zwald M, Hoots B, Yard E, D'Inverno A, Swedo E, Chen MS, Petrosky E, Board A, Martinez P, Stone DM, Law R, Coletta MA, Adjemian J, Thomas C, Puddy RW, Peacock G, Dowling NF, Houry D. Trends in US Emergency Department Visits for Mental Health, Overdose, and Violence Outcomes Before and During the COVID-19 Pandemic. JAMA Psychiatry. 2021 Apr 1;78(4):372-379. doi: 10.1001/jamapsychiatry.2020.4402.

  PMID: 33533876 BACKGROUND

• United Nations Office of Drugs and Crime. World Drug Report 2020 Booklet 1. Available from https://wdr.unodc.org/, Accessed 10/02/2021.

  BACKGROUND

• World Health Organisation. Opioid overdose. August 2020. Available from: https://www.who.int/, Accessed 10/02/2021

  BACKGROUND

• Scottish Government. Evidence=-Based Strategies for Preventing Drug-Related Deaths in Scotland, Our Emergency Response. January 2020. Available from https://www.gov.scot/. Accessed 10/02/2021

  BACKGROUND

• McDonald R, Strang J. Are take-home naloxone programmes effective? Systematic review utilizing application of the Bradford Hill criteria. Addiction. 2016 Jul;111(7):1177-87. doi: 10.1111/add.13326. Epub 2016 Mar 30.

  PMID: 27028542 BACKGROUND

• Giglio RE, Li G, DiMaggio CJ. Effectiveness of bystander naloxone administration and overdose education programs: a meta-analysis. Inj Epidemiol. 2015 Dec;2(1):10. doi: 10.1186/s40621-015-0041-8. Epub 2015 May 22.

  PMID: 27747742 BACKGROUND

• Leino K, Mildh L, Lertola K, Seppala T, Kirvela O. Time course of changes in breathing pattern in morphine- and oxycodone-induced respiratory depression. Anaesthesia. 1999 Sep;54(9):835-40. doi: 10.1046/j.1365-2044.1999.00946.x.

  PMID: 10460553 BACKGROUND

• Chu M, Nguyen T, Pandey V, Zhou Y, Pham HN, Bar-Yoseph R, Radom-Aizik S, Jain R, Cooper DM, Khine M. Respiration rate and volume measurements using wearable strain sensors. NPJ Digit Med. 2019 Feb 13;2:8. doi: 10.1038/s41746-019-0083-3. eCollection 2019.

  PMID: 31304358 BACKGROUND

• Winhusen T, Theobald J, Lewis D, Wilder CM, Lyons MS. Development and initial testing of a tailored telephone intervention delivered by peers to prevent recurring opioid-overdoses (TTIP-PRO). Health Educ Res. 2016 Apr;31(2):146-60. doi: 10.1093/her/cyw010.

  PMID: 27004905 BACKGROUND

• Nandakumar R, Gollakota S, Sunshine JE. Opioid overdose detection using smartphones. Sci Transl Med. 2019 Jan 9;11(474):eaau8914. doi: 10.1126/scitranslmed.aau8914.

  PMID: 30626717 BACKGROUND

• Medical research Council , Biomedical Catalyst. 2021. Available from: https://mrc.ukri.org/funding/science-areas/translation/biomedical-catalyst/

  BACKGROUND

• McDonald R, Campbell ND, Strang J. Twenty years of take-home naloxone for the prevention of overdose deaths from heroin and other opioids-Conception and maturation. Drug Alcohol Depend. 2017 Sep 1;178:176-187. doi: 10.1016/j.drugalcdep.2017.05.001. Epub 2017 May 25.

  PMID: 28654870 BACKGROUND

• Community Management of Opioid Overdose. Geneva: World Health Organization; 2014. Available from http://www.ncbi.nlm.nih.gov/books/NBK264311/

  PMID: 25577941 BACKGROUND

• EMCDDA (2018) Preventing overdose deaths in Europe.

  BACKGROUND

• National Institute for Drug Abuse (2017) Naloxone for Opioid Overdose: Life Saving Science. Available online at: https://www.drugabuse.gov/publications/naloxone-opioid-overdose-life-saving-science/naloxone-opioid-overdose-life-saving-science

  BACKGROUND

• Bird SM, McAuley A. Scotland's National Naloxone Programme. Lancet. 2019 Jan 26;393(10169):316-318. doi: 10.1016/S0140-6736(18)33065-4. No abstract available.

  PMID: 30696566 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Opiate Overdose

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Drug Overdose; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Narcotic-Related Disorders; Mental Disorders

Study Officials

• David J Lowe, MBChB BMSc FRCEM

  NHS Greater Glasgow and Clyde

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: May 3, 2022
• Study Start: June 8, 2022
• Primary Completion: January 7, 2023
• Study Completion: March 7, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

GB (1)