Study Design
A prospective observational study of eCPR cases complimented by a translational simulation pilot phase. Descriptions and analysis of team performance during eCPR are foregrounded. The methods were adapted from the literature on ‘surgical sabermetrics’ and ED ‘design thinking’.9–12 Key aspects are reported using a STROBE diagram (Fig. 1). Patients did not receive additional intervention(s) outside of routine care as the result of enrolment.
Study Setting
Ethics committee [Internal Review Board] (Ref 2021/ETH11970) approval was granted pre-commencement. The need for informed patient consent was waived by the committee due to: (i) impracticality in cardiac arrest; (ii) no patient data being identifiable AND (iii) no change in management. The staff members enrolled provided written consent for participation in the study.
Conduct adhered to Australian guidelines on use of data and privacy. We obtained approval for two eCPR practicing hospitals. Both sites (Westmead Hospital and Royal Prince Alfred) are Level 1 Trauma and Cardiac Surgery centres. These sites both provide similar eCPR care, including a highly selective ED-based eCPR responses for refractory cardiac arrest.
eCPR Model of Care
The eCPR model of care is similar to the established major trauma response systems at the two sites. For eCPR“CODE ECMO” was the standard term used for activation.14 These activations operate on weekdays-only between 0700–1700. The aligned approach to eCPR at the two sites has been previously reported.14 CODE ECMO activations send a text message and/or pager message to pre-allocated eCPR staff. The various checklists used are presented on a free smart phone ‘app’ available for both Apple and Android platforms (i.e., https://apps.apple.com/au/app/westmead-ecmo-app).
Translational Simulation Pilot (February 2022 - March 2022)
During a 2-month pilot study we observed in-situ simulations and trauma cases to test feasibility of data collection. Individual, team, and environmental observations were recorded by two investigators in real time (Appendix 1; Appendix 2). Validated scores of teamwork were also recorded (Appendix 3). Logistical data collection challenges were identified and a standardised data sheet optimised for use in eCPR cases. Pilot data is presented in Appendix 1. In the a-priori protocol additional variables were approved (movement tracking, pedometers) but were deemed impracticable and excluded after the pilot.
A notable component of the pilot (Fig. 1) was the deliberate use of simulation and pilot trauma cases to refine our data-collection processes before enrolling eCPR cases. This preparatory phase allowed to testing of feasibility, anticipation of researcher workflows, and efficient processing of stress-response sampling. Further, the pilot allowed environmental measurements and teamwork assessments to reliably be integrated in real-time. The value of simulation for refining research protocols is increasingly recognised; similar benefits have been demonstrated by Fatovich and co-authors who showed that embedding research into resuscitation simulation improved recruitment into complex clinical trials.15
eCPR Cases (March 2022 - December 2024)
eCPR cases were included based on availability of investigators to observe (AC, HC, AS). We received assistance from an ED research assistant when available. The inclusion criteria were: (i) patient presenting with OUT-OF-HOSPITAL cardiac arrest (OHCA); AND (ii) Activation of eCPR team (criteria aligned with international standards)’; AND (iii) informed consent of all directly observed team members (eCPR providers) in advance of the OHCA arrival. The Exclusion criteria (Fig. 1) were: (i) eCPR case age ≤ 18; (ii) in-hospital cardiac arrests; (iii) cardiac arrest > 1-hour after presentation to the ED; (iv) cardiac arrest following trauma; (v) refusal of provider(s) to participate; (vi) no availability of researcher(s) to observe. Key health providers (i.e., cannulators) were consented in advance where possible to avoid interferences with workflow and eCPR preparation.
Case Sampling
For a convenience sample of “observation of processes, team and health provider factors” we aimed to enrol > 5 eCPR cases and > 15 team (discrete) team members. No power calculations were made. As noted, core eCPR team members were enrolled in advance. Team members such as eCPR cannulators routinely know they are part of the team (i.e., carrying a pager).
Eligible key eCPR providers included Team Leaders (Medical, Crowd Control and Nursing), CPR (defibrillation) nurses, eCPR cannulators and airway doctors. For each case a capped number of team members were enrolled (i.e., maximum of four due to limited monitoring equipment). The local eCPR team on-boarding process encourages team members to be familiar with their role and take a team lanyard (Fig. 4) to identify their role during the case.
Outcome Measures
The overall approach was to adopt a pragmatic data collection strategy informed by prior work in trauma and simulation settings.8,11 The choice of outcomes aligned with testing a hypothesis that ‘effective eCPR performance is dependent on alignment between individual stress regulation, coordinated teamwork, and contextual affordances.’ Accordingly, we selected feasible, low-cost measures from 4 domains (i.e., self, team, environmental and system). Observation of actual eCPR performance under real world conditions provided a robust but limited number of cases to observe for these factors.8 11 We took the learnings from work by Yule (sabermetrics), Hicks (ED trauma) and LeBlanc (team stress) as well as experience from the pilot to select a final list of feasible outcome measures.9 14 18
In more detail, the sampling strategy sought to capture complementary dimensions of performance across key interrelated domains relevant to NTS performance in eCPR. These domains included * Individual Factors (focussing on individual response outcomes); ** Team Factors (focussing on teamwork outcomes) and *** Environmental Factors (focussing on environmental outcomes). The outcome measures used were conceptually linked rather than discrete. Specifically, the measures were chosen to broadly represent the interdependent domains within Reid’s 2018 framework (e.g., self, team, environment and system factors that relate to performance in high stakes resuscitations).18 The pilot work (Appendix 1) informed the feasibility of data collection and assisted with refining the data collection sheets. After the pilot study we adopted an integrated data collection strategy to explain how Reid’s domains. The specific measures (listed below) were chosen because each domain can interact and influence the others. For example, environmental noise may influence stress and impede teamwork - whilst clear system design and team training could mitigate such effects. In the resulting discussion section, we provide interpretations of the resulting data set within the context of the literature on non-technical skills and human factors in healthcare. This approach allows us to move beyond summarising results and instead discuss how the domains collectively shape performance during eCPR. This informs the overarching goal of providing recommendations for eCPR training and systems. For each eCPR case enrolled two researchers collected the following outcomes for each case:
(i) Utstein and eCPR Patient Outcomes - Utstein outcomes were available for each case using a pre-existing OHCA registry.3 Enrolment did not alter the clinical management of patients. Cases are reported with cardiac arrest outcomes relevant to appropriateness of selection (i.e. rhythm, time of arrest pre-hospital), the eCPR process (i.e., cannulation start time, finish time) and mortality at 1-day/28-days.
(ii) Salivary Cortisol*- Hypothalamic Pituitary Adrenal system activation can be reliably measured using salivary testing by Enzyme-Linked Immunosorbent Assay (ELISA). Cortisol ELISA sampling shows correlation narrow limits of agreement with plasma cortisol.1119 Samples were taken both at baseline (matched time to eCPR case) and 0.5 to 2 hours following the eCPR case (i.e., cortisol typically peaks at around 45 minutes post event). Available participants were asked to roll a specific salivary sampling tampon in their mouth until saturated (i.e., 1-minute). Samples were placed in collection tubes and frozen for analysis at RPA hospital.
(iii) Heart Rate Monitoring*- Heart rate (HR) is considered a useful dependent stress measure.20 Heart rate variability (HRV) is superior to raw heart rate as a measure, but we did not have resources to cover devices to measure HRV. Polar H10 mobile bands (Polar Electro, Kempele, Finland) supplied by the local Simulation Centre ($580 for purchase of 3) for the duration of study. These bands were linked to an IOS device by Bluetooth (https://support.polar.com/au-en/polar-team-app) that recorded HR continuously. Baseline HR was not measured so data is limited to descriptive reporting.
(iv) State Trait Anxiety Index (STAI)*- The State-Trait Anxiety Inventory (STAI) is a widely used psychological scale for measuring anxiety in adults. It was developed by Spielberger and colleagues. The STAI is divided into two self-report scales (Y1 State and Y2 Trait). In a previous studies of stressful simulations use of the scales were sensitive to anxiety increases.11 The scores on each item are collated into a anxiety score, which can range from 20 to 80 with a high reported level of internal consistency.21 The state anxiety scale of the STAI consists of 20 statements (e.g., ‘‘I am tense’’) to which respondents indicate agreement on a four-point scale as to how they feel at the given moment. Paper forms were used to collect both Y1 and Y2 scores within 6 hours of the eCPR event.
(v) Mayo High Performance Teamwork Score (MHPTS)** - We measured the validated items of the MHPTS score for all cases. MHPTS is a score of teamwork with a score of 0–16 (Appendix 3). For a secondary measure to assess teamwork factors more specific eCPR we used a second team checklist derived from work by Weller and co-authors (Appendix 2).22 A combination of both MHPTS (Appendix 3) and the Weller derived checklist (Appendix 2) is relevant to eCPR because it occurs in a critical care team context.1423 In the manuscript we denote the Weller checklist as the “Modified Auckland Score”. Investigators (two for each case) also took notes on major teamwork omissions. Discrepancy in scoring/observations/notes were resolved by consensus or by use of a median score.
(vi) Ambient Noise Level (Decibels)*** - Room volume was continuously monitored via a National Institute for Occupational Safety and Health (NIOSH) Sound Level Meter system. A calibrated microphone was connected to a spare dedicated smartphone.22 Sound levels have been measured extensively in operating rooms with similar methods.23–26 A-weighted sound levels (LAeq) and the C-weighted peak sound pressure (LCpeak) were displayed on the device and recorded onto the paper sheet (Appendix 2). As this system provides a diachronic trace of these values, decibel values were manually recorded each minute, and the peak volume captured noted at patient departure. Microphones were placed to the centre left of the resuscitation room which is part of an open area Resuscitation Bay measuring approximately 60m2 (Fig. 3).
Analysis Plan and Bias
Extensive comparative analysis was limited due to a limited sample size (Fig. 1). As a result, we describe the majority of the data set descriptively. Post-hoc comparative analyses using t-tests was applied by a progressional statistician to a limited number of normally distributed variables with larger sample sizes (i.e., noise level (DB). The analysis was conducted using IBM SPSS Statistics (version 19). There was no control for confounders or use of any sensitivity analyses. The literature provides a number of comparable studies which assist in interpreting and make meaning the specific results.