RESpiratory monitoring reduCing drUg harm, the RESCU project
Research type
Research Study
Full title
RESpiratory monitoring reduCing drUg harm, the RESCU project
IRAS ID
301153
Contact name
John F Dillon
Contact email
Sponsor organisation
University of Dundee
Duration of Study in the UK
1 years, 6 months, 2 days
Research summary
Summary of Research
Accidental overdose is the most common cause of mortality among people who use drugs (PWUD). Scotland is in the midst of a drug related deaths (DRD) crisis, and has observed a two fold increase in drug related deaths between 2009 and 2019. Within secondary care environments, monitoring of opioid-induced respiratory depression (OIRD) can be easily achieved with available technology and the safety of participants assured. However, this technology has not been readily transferable to community environments until recently. Altair Medical are developing Pneumowave technology - an artificial intelligence (AI) driven remote respiratory monitoring platform consisting of a small, wearable chest biosensor and proprietary algorithms that aim to detect life-threatening events in real-time. When features indicative of abnormal breathing are detected, these devices have the potential to alert individuals, household members, friends and family, or emergency services, who can intervene to administer lifesaving naloxone.
Understanding the acceptability of the device within a cohort of PWUD is a fundamental parameter for successful implementation. In order to inform proprietary algorithms that analyse respiratory patterns and can detect OIRD, it is necessary to passively collect baseline respiratory data to understand the variation in normal respiratory patterns among PWID. A cohort of up to 100 participants who attend needle exchanges in the geographical area of NHS Tayside will be recruited. The study will involve 5 study visits over 4 weeks, and participants will be required to continuously wear the biosensor, providing passive respiratory data. Additionally, participants will be instructed on the completion of a paper diary to record when they are taking illicit and prescribed drugs during study participation. A parallel phase of the study will utilise semi structured interviews and focus groups with key stakeholders (participants, friends and family, services) to inform the development of a clinical intervention pathway using the Pneumowave technology.
Summary of Results
70 participants were recruited from an injection equipment site in Dundee (Feb–Dec 2022) and used biosensors to record breathing over four weeks. Interviews and focus groups with participants (n=21) and stakeholders
(n=8) explored device acceptability. Qualitative data analysis used Reflexive Thematic Analysis, COM-B, and Normalisation Process Theory.Qualitative Data
Semi-structured interviews and focus groups were conducted with participants who completed the study protocol (n=20), partially completed the study protocol (n= 1) and stakeholder groups (n=8) about device acceptability. Verbatim transcripts were analysed using reflexive thematic analysis. Factors influencing device acceptability for PWUD were interpreted using the concepts of the COM-B behaviour model. Discussions around implementation with stakeholder groups utilised Normalisation Process Theory to further appraise the intervention and its integration into existing services.
Experiences with overdose or drug-related deaths (DRD) were identified within qualitative data as motivating factors for device wear. First responder groups stressed the importance of patient choice and device accuracy. The accelerometer sensor was found to be acceptable to PWUD and was utilised to monitor respiratory patterns. Stakeholders recognised the potential of such a device to play a part in the management of overdose and identified necessary requirements to ensure successful implementation of the device, such as funding allocation, potential barriers and integration into existing services.
The chest-worn biosensor was acceptable to people who use drugs, driven by personal experiences with overdose risks, and were viewed by stakeholders as a promising tool for overdose management. Successful implementation will require ensuring device accuracy, respecting patient choice, securing funding, and integrating the technology into existing services.
Quantitative Data
Respiratory data
was analysed using algorithms detecting pauses in respiration. A Delphi study is currently being conducted to determine ideal response time in the event of a respiratory arrest.48 participants returned with at least one week of data, however five participants' data had to be discarded due to becoming corrupted in storage. 43 participants who returned data contributed 5,761 hours of data (2,365 hours of which were respiratory data), averaging 134 hours of data collected per each participant. Focusing on apnoeic episodes of over 30s of which there were >3 apnoeic episodes within an hour, participants experienced 851 of such apnoeic episodes, most during respiratory depression.
Experiences with overdose or DRD were identified as motivating factors for device wear. First responders emphasised patient choice and device accuracy. Therapeutic relationships between staff and clients of the injection equipment provision site were found to be beneficial for intervention uptake.Of the 5761 recorded hours of data, of which
2364.78 hours were respiratory data. On average, participants were monitored for 28 days (672 hours).The participants
returned with an average of 133.97 recorded hours of data per participant (SD 104.44), of which an average of 54.99 hours were respiratory data (SD: 55.87).Participants returned
with an average coverage of time on study being 20.04% (SD: 14.67%) of which 8.28% was respiratory data (SD: 7.90).Respiratory data was categorized using the respiratory rate portion of the National Early Warning Score 2 (News Score 2), in which severe respiratory depression is categorized as eight breaths per minute and below, respiratory depression is categorized as 9-11 breaths per minute, normal respiration is classed as between 12 and 20 breaths per minute and hyperventilation and severe hyperventilation as being classed between 21-24 and 25 breaths per minute and above respectively.
40% of participant data was within the normal range of respiration, 36% was within the range of respiratory depression and 20% was within range of severe respiratory depression. Hyperventilation and severe hyperventilation were detected at 3% and 1% of the recorded respiratory data respectively. The average respiratory rate was 10.74 breaths per minute (SD: 3.35).
The Delphi Study
The Delphi study has
identified that apnoeic episodes >30 seconds or three episodes over 20 seconds in 2 minutes should trigger an alarm.In the first round of
the study 73% of participants agreed that a single continuous central apnoeic episode of over 30 seconds is an appropriate duration for an alarm in the proposed device. Likewise, 73% of participants agreed that for repeated central apnoeic episodes, three apnoeic episodes of more than 20s duration in any 2-minute period is an appropriate alarm setting.86% of participants
agreed that it is appropriate for the patient’s own mobile device to emit a near-patient audible alarm to check whether the patient is conscious. If the patient does not respond, household members may hear the alarm. If no response, the device moves to Level 2. 71% of participants agreed that a Level 2 response was appropriate, that is, if neither the patient, nor household members, respond to the near-patient alarm, third-party responders can be notified via an automated phone call. 73% of participants agreed that emergency medical services can also be notified.When asked about
audible prompts to a true alarm, there was consensus that at least three audible prompts are necessary to determine if the patient is conscious before sending out an automated phone call.From the free-text
responses, we used Nvivo 12.6 to conduct thematic analysis in order to conduct a thematic analysis in which we identified three key themes: intervention suitability, threshold settings and resource implications. These themes were used to generate the statements for the second round of the Delphi study.In the second round of
the Delphi study, 83% of the participants agreed that three audible prompts should sound before an alarm is sounded. 83% of the participants agreed that an audible prompt should sound every time an apnoeic episode over 30 seconds is detected, or three 20 second episodes in a 2 minute interval are detected, echoing the results of the previous round. 83% of participants were disagreeing
(64%) to remaining neutral (19%) that device users should be allowed to adjust the timings of the device themselves. The example that was given was adjusting the alarm response to be between 20-40s length of an apnoeic episode. 72% of participants were neutral (17%) to agreeing (55%) that patients who are at risk (e.g. with a previous history of non-fatal overdose) should have a lower threshold for emergency response. 73% of participants were in agreement to strong agreement that an audible prompt would be heard by bystanders in the vicinity and would motivate bystanders to intervene.REC name
South East Scotland REC 02
REC reference
21/SS/0074
Date of REC Opinion
1 Nov 2021
REC opinion
Further Information Favourable Opinion