Cardiopulmonary Arrest, Pediatric, Resuscitation
Conditions
Keywords
Cardiopulmonary Resuscitation, Augmented Reality, Digital Health, Pediatrics
Brief summary
A prospective, multicenter, randomized clinical trial in two tertiary pediatric emergency department. It will assess, amongst pediatric healthcare teams, whether the use of augmented reality supportive devices improves adherence to American Heart Association (AHA) advanced life support guidelines and performance, while reducing medication errors, when compared to groups using the AHA pocket reference card (control) during standardized, simulation-based, pediatric in-hospital cardiac arrest (IHCA) scenarios. Seventy participants will be randomized. The primary endpoint is the time to first dose of epinephrine.
Detailed description
Each year, thousands of children experience cardiopulmonary arrests (CA), requiring immediate and accurate resuscitation for favorable outcomes. However, adherence to American Heart Association (AHA) advanced life support guidelines remains suboptimal, hindered by cognitive and communication challenges in high-stress cardiopulmonary resuscitation (CPR) situations. To address this problem, will assess a novel augmented reality (AR)-assisted digital health solution designed to offer personalized, real-time decision support for team leaders and medication nurses, while concurrently optimizing team situational awareness and communication by projecting a dynamic care roadmap onto a large screen in the resuscitation room, controlled via a mobile tablet app. The solution comprises three essential digitally interconnected elements: 1) a mobile app that presents clinical algorithms alongside patient data, guiding the resuscitation team through step-by-step procedures, 2) a giant screen that displays real-time patient information and task progress for the entire resuscitation team, and 3) augmented reality devices worn by team members, providing role-specific guidance and decision support based on data collected by the app. In this trial, we will assess, amongst pediatric healthcare teams, whether the use of the AR-assisted tool improves adherence to AHA resuscitation guidelines and performance, while reducing medication errors, when compared to groups using the AHA pocket reference card (control) in an open-label, prospective, multicenter, cluster randomized (1:1 ratio) clinical trial. Sixty physicians and nurses will be recruited to form teams of 7, each managing simulated pediatric in-hospital cardiac arrest (IHCA) scenarios using either an AR-assisted tool or conventional AHA pocket reference cards. Each team will comprise three participants assigned to the roles of 1) Team Leader (a physician), 2) Charting Nurse, and 3) Medication Nurse, with two CPR Providers, an Airway Provider, and a Bedside Provider roles filled by research actors. All participants and actors will view a CPR Coach orientation video to ensure understanding of the CPR Coach and Provider functions The primary outcome is the time in seconds to first dose of epinephrine. Secondary outcomes are times to CPR initiation, defibrillation, drug delivery, airway securing, the rate of medication errors, CPR pause frequency, CPR quality (excellent CPR percentage, chest compression fraction, peri-shock pause duration), provider workload (NASA-TLX survey) and stress (STAI), user experience (UEQ), system usability (SUS), and technology acceptance (UTAUT).
Interventions
DEVICEAugmented reality supportive tool
Participants will view a standardized orientation video describing the clinical environment, equipment, manikin functionality, and participant roles, followed by a 15-minute table-top practice simulation where participants have opportunity to use the assigned intervention by running through a cardiac arrest scenario. Then, participants will undertake a 20-minute tightly standardized cardiac arrest simulation scenario using a high-fidelity pediatric manikin. The scenarios will be videotaped from a bird's-eye view angle at the foot of the bed, along with three action video cameras worn by the participants, and positioned within the room. Following completion of the scenario, participants will fill out five surveys (see secondary outcomes), which together take about 15 minutes to fill.
OTHERConventional method (AHA pocket reference card)
Participants will view a standardized orientation video describing the clinical environment, equipment, manikin functionality, and participant roles, followed by a 15-minute table-top practice simulation where participants have opportunity to use the assigned intervention by running through a cardiac arrest scenario Then, participants will undertake a 20-minute tightly standardized cardiac arrest simulation scenario using a high-fidelity pediatric manikin. The scenarios will be videotaped from a bird's-eye view angle at the foot of the bed, along with three action video cameras worn by the participants, and positioned within the room. Following completion of the scenario, participants will fill out five surveys (see secondary outcomes), which together take about 15 minutes to fill.
Sponsors
University Hospital, Geneva
Alberta Children's Hospital
Johan Siebert, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
It will not be possible to blind study participants to study arm allocation due to the nature of the intervention(s), but they will be blinded to study objectives. The statistician will be blinded regarding the allocation of participants to the study arms for results analysis.
Intervention model description
Open-label, prospective, multicenter, cluster randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Inclusion criteria for the team leader include: attending physician, fellow, or senior resident in emergency medicine, pediatric emergency medicine, pediatrics, pediatric critical care, or pediatric anesthesia. * Inclusion criteria for the medication and charting nurse roles include: nurse in pediatric emergency medicine, general pediatrics, or other pediatric acute care specialty. * Inclusion criteria for all other team members include: pediatric attending physician, resident, fellow, nurse or respiratory therapist. * Participants must have prior basic life support training. * Participation agreement.
Exclusion criteria
* Decline to provide informed consent * Previously enrolled * Unable to perform tasks required of the role
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first dose of epinephrine | 20 minutes | The primary outcome is the time in seconds to first dose of epinephrine administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to defibrillation | 20 minutes | The time in seconds from the investigator's clinical statement to each manual defibrillator shock delivery |
| Time to delivery of epinephrine | 20 minutes | The time in seconds from the investigator's clinical statement to intravenous injection of epinephrine to treat underlying condition |
| Time to delivery of amiodarone | 20 minutes | The time in seconds from the investigator's clinical statement to intravenous injection of amiodarone to treat underlying condition |
| Time to secure definitive airway | 20 minutes | The time in seconds from the investigator's clinical statement to the successful establishment of a definitive airway via endotracheal intubation |
| Medication dosage errors | 20 minutes | Errors in drug dose administration (milligrams), defined as a deviation from the correct weight-based dose of more than 10% according to predefined, expert consensus-based criteria, will be measured (i.e., absolute and percentage deviation) in each allocation group as a deviation from the 2020 AHA Pediatric Advanced Life Support cardiac arrest algorithm. |
| Types of Medication Errors | 20 minutes | The nature of the error type will be recorded, such as incorrect drug selection (i.e., administering the wrong medication), administration timing errors (i.e., administering the medication at the wrong time during the resuscitation process), labeling errors (i.e., misinterpreting or misreading the medication label), equipment-related errors (i.e., issues related to the functioning or availability of equipment needed for drug administration \[e.g., syringe malfunction\]), and documentation errors (i.e., inaccurate or incomplete recording of medication administration details) |
| Frequency of Medication Errors | 20 minutes | Number of times medication errors occur during the cardiac arrest scenario |
| Frequency of pauses in cardiopulmonary resuscitation | 20 minutes | Number of times of cardiopulmonary resuscitation pauses during the cardiac arrest scenario |
| Duration of pauses in cardiopulmonary resuscitation | 20 minutes | The total time in seconds of cardiopulmonary resuscitation pauses during the cardiac arrest scenario |
| Causes of pauses in cardiopulmonary resuscitation | 20 minutes | The causes leading to resuscitation interruptions will be identified and documented |
| Time to initiation of cardiopulmonary resuscitation | 20 minutes | The time in seconds from the investigator's clinical statement to initiation of chest compression |
| Cardiopulmonary resuscitation quality: Chest compression fraction | 20 minutes | The fraction of time in seconds that chest compressions are being performed over the total cardiopulmonary resuscitation duration |
| Cardiopulmonary resuscitation quality: Peri-shock pause duration | 20 minutes | The length of time in seconds between the cessation of chest compressions and the delivery of a defibrillation shock during cardiopulmonary resuscitation |
| Provider workload (NASA-TLX) | 15 minutes | Assessed via NASA-TLX. It measures mental burden across 6 dimensions: mental, physical, temporal demands, performance, effort, and frustration. Scores range from 0 to 100 in 5-point increments (0: no task load; 100: maximal task load). Participants rate each dimension based on their perceived workload. To combine the dimensions into a final score, a weighting procedure is used. This involves comparing each dimension with every other dimension to determine its relative importance in influencing workload. Participants select the dimension that contributes most to workload in each pair of comparisons. Each dimension is then weighted based on the participant's selections, with higher weights given to dimensions that are chosen more frequently. The weighted scores for each dimension are summed to calculate the overall score, which ranges from 0 (minimal task load) to 100 (maximal task load) |
| User Experience Questionnaire (UEQ) | 15 minutes | UEQ is a widely used questionnaire to measure the subjective impression of users towards the user experience of products. The UEQ is a semantic differential with 26 items that are grouped into six scales (Attractiveness, Perspicuity, Efficiency, Dependability, Stimulation, and Novelty). Each scale represents a distinct usability quality aspect. The minimum value is 0 (i.e., the worst user experience) and the maximum value is 100 (i.e., the best user experience). Participants will be asked to complete the UEQ directly after they have completed the resuscitation scenario |
| System Usability Scale (SUS) | 15 minutes | SUS is a widely used questionnaire for assessing the perceived usability of a system or product. The SUS consists of a 10-item questionnaire where users rate their agreement or disagreement with a series of statements regarding the usability of a system using a 5-point Likert scale (1 to 5). The minimum value is 0 (i.e., the system is not usable) and the maximum value is 100 (i.e., the system is absolutely usable). Participants will be asked to complete the SUS directly after they have completed the resuscitation scenario |
| Unified Theory of Acceptance and Use of Technology questionnaire (UTAUT) | 15 minutes | The UTAUT consists of eight domains (performance expectancy, effort expectancy, social influence, facilitating conditions, hedonic motivation, price value, habit, and behavioural intention). This measure will be adapted to assess participants' perceived usability, usefulness, and intention to use the augmented reality-aided tool after study completion. Responses are rated on a 7-point likert scale from 1=Strongly disagree to 7=Strongly agree. Participants will be asked to complete the UTAUT directly after they have completed the resuscitation scenario |
| State-Trait Anxiety Inventory (STAI) form Y-1 | 15 minutes | This questionnaire is composed of 20-item self-report subscales to measure the temporary state of anxiety at the time of reporting (STAI form Y-1), which can be affected by stressful situations. Each item is answered on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much). After reversing the scores for stress-absent items (ie, items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20), the total score is calculated by summing up the weighted scores for the 20 items. STAI ranges from 20 to 80, with higher scores being positively correlated with greater stress. The range of possible scores range from a minimum score of 20 to a maximum score of 80. STAI scores are commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80). Participants will be asked to complete the STAI directly after they have completed the resuscitation scenario |
| Visual attention patterns of team leader and medication nurse on augmented reality and resuscitation room elements | 20 minutes | Duration and number of visual fixations on pre-defined area of interest (AOI) for the team leader and medication nurse, as captured by the augmented reality device (Microsoft Hololens2). AOIs will include the holograms projected within each augmented reality device, as well as the LCD screen within the resuscitation room and manikin for the team leader. |
| Team Emergency Assessment Measure (TEAM) survey | 10 minutes | The TEAM survey is a validated tool designed to assess team performance during emergency scenarios, focusing on non-technical skills. It consists of 11 items rated on a 5-point Likert scale (0 \[Never/Hardly ever\] to 4 \[Always/Nearly always\]) across three domains: Leadership, Teamwork, and Task Management, with an additional overall performance rating. Scores range from 0 (poor performance) to 44 (excellent performance), providing a comprehensive measure of team dynamics, communication, and coordination. Participants will complete the TEAM survey immediately after each resuscitation scenario to evaluate the team's effectiveness in managing the simulated IHCA |
| Concise Assessment of Leader Management (CALM) Survey | 10 | The CALM survey is a validated tool for assessing leadership in acute resuscitation scenarios, focusing on the Team Leader's performance. It includes 15 four-point Likert scale items (rarely, sometimes, mostly, always) across 4 domains-Leadership (role and style, 2 items), Communication (clarity and closed-loop reinforcement, 2 items), Team Management (role assignment, task direction, workload balance, team engagement, and case summarization, 5 items), and Medical Management (task prioritization, global awareness, patient reassessment, care planning, and help-seeking, 5 items)-plus 1 dichotomous behavioral item (yes/no on role announcement) and 1 global rating item comparing the leader to peers (below expected, as expected, above expected, top 5%). Scores for the Likert items range from 15 (poor leadership) to 60 (outstanding leadership), with additional binary and comparative assessments. Team members will complete the CALM survey immediately after each resuscitation scenario. |
| Cardiopulmonary resuscitation quality: Percentage of overall excellent cardiopulmonary resuscitation | 20 minutes | The proportion of cardiopulmonary resuscitation administrations that meet the predefined AHA standards for high-quality resuscitation techniques. |
Countries
Canada, Switzerland
Outcome results
None listed