ARM-ED: Advanced Respiratory Monitoring Events in Drug Toxicity

Respiratory Insufficiency Clinical Trial

— ARM-ED  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05358132
• Other study ID #: INGN21RM077
• Status: Recruiting
• Start date: June 8, 2022
• Est. completion date: March 7, 2024

Study information

• Verified date: July 2023
• Source: NHS Greater Glasgow and Clyde
• Contact: Lisa C Dunlop, MBChB, BSc FRCEM
• Phone: 0141 452 2930/1
• Email: lisa.dunlop2[@]nhs.scot
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 7, 2024
• Est. primary completion date: December 7, 2023
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Overdose
• Drug-Related Side Effects and Adverse Reactions
• Opiate Overdose
• Overdose of Opiate
• Respiratory Insufficiency
• Sedative Overdose
• Sedative Toxicity

Intervention

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,

Locations

Country	Name	City	State
United Kingdom	Emergency Department, Queen Elizabeth University Hospital	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	Pneumowave Ltd

Country where clinical trial is conducted

United Kingdom, 

References & Publications (19)

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. — View Citation

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. — View Citation

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

EMCDDA (2018) Preventing overdose deaths in Europe.

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

Nandakumar R., Gollakota S.,Sunshine J.E. (2019) Science Translational Medicine: 11; eaau8914 Available online at: https://stm.sciencemag.org/content/11/474/eaau8914

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

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.

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

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

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. — View Citation

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

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of times device removed by patient / other	Number of times device removed total during each study episode.	1 year
Primary	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	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
Secondary	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
Secondary	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