ARM-ED: Advanced Respiratory Monitoring Events in Drug Toxicity

NHS Trust

Status

Completed

Conditions

Overdose of Opiate

Respiratory Insufficiency

Sedative Toxicity

Sedative Overdose

Treatments

Device: Pneumowave Device placement and data capture

Study type

Observational

Funder types

Other

Identifiers

NCT05358132

INGN21RM077

Details and patient eligibility

About

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.

Full 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.

Enrollment

78 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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