An observational study in Respiratory Insufficiency, Overdose of Opiate and Sedative Overdose, sponsored by NHS Greater Glasgow and Clyde. Completed at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-06-21.
Sponsored by NHS Greater Glasgow and Clyde · Observational
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.
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.
1,369 studies on the registry are indexed under Respiratory Insufficiency; 264 are open to participants now.
This study's enrollment of 78 is below the median of 100 across 455 observational studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →NHS Greater Glasgow and Clyde is the lead sponsor of 220 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Group 1 - Acute toxicity group
Group 2 - PSA group
Exclusion Criteria:
Group 1 - Acute toxicity group
Group 2 - PSA group
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients attending the Emergency Department with acute sedating drug toxicity
Device: Pneumowave Device placement and data capture
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,
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.
Time frame: 1 year
Number of times device removed by patient / other
Number of times device removed total during each study episode.
Time frame: 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.
Time frame: 1 year
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
Time frame: 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
Time frame: 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)
Time frame: Duration of study period, up to 15 months
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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