Respiratory InsufficiencyARM-EDNCT05358132
ARM-ED: Advanced Respiratory Monitoring Events in Drug Toxicity
An observational study of Respiratory Insufficiency and Overdose of Opiate, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Respiratory Insufficiency, Overdose of Opiate, Sedative Overdose
- What is being tested?
- Pneumowave Device placement and data capture
- Type of treatment
- Medical device
- How many people
- 78 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Jun 2022to 7 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
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
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- Group 2 - PSA group
- Unable to provide consent
- Treating clinician deems patient inappropriate to be included in study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Emergency Department, Queen Elizabeth University Hospital
Glasgow, G51 4FT
About this study
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
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.
Read the 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.
- Being tested
- Pneumowave Device placement and data capture
- Medical subject headings
- Respiratory Insufficiency, Opiate Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumowave Device placement and data captureDevice
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,
| Study group | Role | What they receive |
|---|---|---|
| ARM-ED group 1 - Acute toxicity group | Patients attending the Emergency Department with acute sedating drug toxicity Receives: Device: Pneumowave Device placement and data capture | |
| ARM-ED group 2 - PSA group | Patients undergoing procedural sedation and analgaesia in the Emergency Department Receives: Device: Pneumowave Device placement and data capture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Number of times device removed by patient / other
Number of times device removed total during each study episode.
Measured: 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.
Measured: 1 year
Secondary outcomes (3)
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
Measured: Duration of study period, up to 15 months
Compare Pneumowave respiratory wave patterns to clinical events
Compare Pneumowave respiratory wave patterns to clinical events:
- Normal respiratory patterns
- Clinical deterioration
- Interventions in ED
Measured: Duration of study period, up to 15 months
Compare respiratory waveform patterns and motion artefact data
Compare respiratory waveform patterns and motion artefact data to:
- GCS
- Richmond Agitation-Sedation Scale (RASS)
Measured: Duration of study period, up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start8 Jun 2022
- Primary completion7 Jan 2023
- Study completion7 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- Pneumowave Ltd
- Responsible party
- Sponsor
- Investigators
- David J Lowe, MBChB BMSc FRCEM, Principal investigator, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358132
- Sponsor's protocol ID
- INGN21RM077
- Acronym
- ARM-ED
- Status last verified
- Jun 2024
- First submitted
- 30 Mar 2022
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Publications
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
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.
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.
PubMed 33533876United Nations Office of Drugs and Crime. World Drug Report 2020 Booklet 1. Available from https://wdr.unodc.org/, Accessed 10/02/2021.
World Health Organisation. Opioid overdose. August 2020. Available from: https://www.who.int/, Accessed 10/02/2021
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
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.
PubMed 27028542Giglio 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.
PubMed 27747742Leino 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.
PubMed 10460553Chu 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.
PubMed 31304358Winhusen 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.
PubMed 27004905Nandakumar R., Gollakota S.,Sunshine J.E. (2019) Science Translational Medicine: 11; eaau8914 Available online at: https://stm.sciencemag.org/content/11/474/eaau8914
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.
PubMed 30626717McDonald 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.
PubMed 28654870
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05358132
- Acronym / sponsor ID
- ARM-ED / INGN21RM077
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- Pneumowave Ltd
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 7 Jan 2023 (actual)
- Study completion
- 7 Mar 2024 (actual)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM-ED group 1 - Acute toxicity group | – | Device: Pneumowave Device placement and data capturePatients attending the Emergency Department with acute sedating drug toxicity |
| ARM-ED group 2 - PSA group | – | Device: Pneumowave Device placement and data capturePatients undergoing procedural sedation and analgaesia in the Emergency Department |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pneumowave Device placement and data captureParticipants 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, | Device | ARM-ED group 1 - Acute toxicity group, ARM-ED group 2 - PSA group |
Primary outcome
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.
Number of times device removed by patient / other
Time frame: 1 year
Number of times device removed total during each study episode.
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.
3 secondary outcomes
Observation of waveform data from Pneumowave device
Time frame: 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 respiratory waveform patterns and motion artefact data
Time frame: Duration of study period, up to 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- BackgroundEMCDDA. 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
- BackgroundNational 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: PubMed 33533876Holland 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.
- BackgroundUnited Nations Office of Drugs and Crime. World Drug Report 2020 Booklet 1. Available from https://wdr.unodc.org/, Accessed 10/02/2021.
- BackgroundWorld Health Organisation. Opioid overdose. August 2020. Available from: https://www.who.int/, Accessed 10/02/2021
- BackgroundScottish 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: PubMed 27028542McDonald 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.
- Background: PubMed 27747742Giglio 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.
- Background: PubMed 10460553Leino 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.
- Background: PubMed 31304358Chu 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.
- Background: PubMed 27004905Winhusen 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.
- BackgroundNandakumar R., Gollakota S.,Sunshine J.E. (2019) Science Translational Medicine: 11; eaau8914 Available online at: https://stm.sciencemag.org/content/11/474/eaau8914
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David J Lowe, MBChB BMSc FRCEM principal investigator
NHS Greater Glasgow and Clyde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Insufficiency and Overdose of Opiate, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of time device in situ on patient (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05358132, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.