Pediatric Clinical Trial
Official title:
Evaluation of an Augmented Reality and Screen-based Decision Support System for Cardiopulmonary Arrest: a Multicenter, Randomized Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 70 |
Est. completion date | October 31, 2025 |
Est. primary completion date | October 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Alberta Children's Hospital | Calgary | Alberta |
Switzerland | Geneva Children's Hospital, Geneva University Hospitals | Geneva |
Lead Sponsor | Collaborator |
---|---|
Johan Siebert, MD | Alberta Children's Hospital, Calgary, Canada, Geneva Children's Hospital, Geneva, Switzerland |
Canada, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to first dose of epinephrine | The primary outcome is the time in seconds to first dose of epinephrine administration | 20 minutes | |
Secondary | Time to initiation of cardiopulmonary resuscitation | The time in seconds from the investigator's clinical statement to initiation of chest compression | 20 minutes | |
Secondary | Time to defibrillation | The time in seconds from the investigator's clinical statement to each manual defibrillator shock delivery | 20 minutes | |
Secondary | Time to delivery of epinephrine | The time in seconds from the investigator's clinical statement to intravenous injection of epinephrine to treat underlying condition | 20 minutes | |
Secondary | Time to delivery of amiodarone | The time in seconds from the investigator's clinical statement to intravenous injection of amiodarone to treat underlying condition | 20 minutes | |
Secondary | Time to secure definitive airway | The time in seconds from the investigator's clinical statement to the successful establishment of a definitive airway via endotracheal intubation | 20 minutes | |
Secondary | Medication dosage errors | 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. | 20 minutes | |
Secondary | Types of Medication Errors | 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) | 20 minutes | |
Secondary | Frequency of Medication Errors | Number of times medication errors occur during the cardiac arrest scenario | 20 minutes | |
Secondary | Frequency of pauses in cardiopulmonary resuscitation | Number of times of cardiopulmonary resuscitation pauses during the cardiac arrest scenario | 20 minutes | |
Secondary | Duration of pauses in cardiopulmonary resuscitation | The total time in seconds of cardiopulmonary resuscitation pauses during the cardiac arrest scenario | 20 minutes | |
Secondary | Causes of pauses in cardiopulmonary resuscitation | The causes leading to resuscitation interruptions will be identified and documented | 20 minutes | |
Secondary | Cardiopulmonary resuscitation quality: Percentage of overall excellent cardiopulmonary resuscitation | The proportion of cardiopulmonary resuscitation administrations that meet the predefined AHA standards for high-quality resuscitation techniques. | 20 minutes | |
Secondary | Cardiopulmonary resuscitation quality: Chest compression fraction | The fraction of time in seconds that chest compressions are being performed over the total cardiopulmonary resuscitation duration | 20 minutes | |
Secondary | Cardiopulmonary resuscitation quality: Peri-shock pause duration | The length of time in seconds between the cessation of chest compressions and the delivery of a defibrillation shock during cardiopulmonary resuscitation | 20 minutes | |
Secondary | Provider workload (NASA-TLX) | 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) | 15 minutes | |
Secondary | User Experience Questionnaire (UEQ) | 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 | 15 minutes | |
Secondary | System Usability Scale (SUS) | 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 | 15 minutes | |
Secondary | Unified Theory of Acceptance and Use of Technology questionnaire (UTAUT) | 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 | 15 minutes | |
Secondary | State-Trait Anxiety Inventory (STAI) form Y-1 | 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 | 15 minutes |
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