Cardiac Arrest (CA), Cardiopulmonary Resuscitation (CPR), Pediatric Cardiac Arrest (Simulated)
Conditions
Keywords
augmented reality, cardiopulmonary resuscitation, pediatric cardiac arrest, cpr quality, chest compressions, cpr coaching, real-time feedback, pediatric advanced life support, simulation
Brief summary
This study evaluates whether an augmented reality cardiopulmonary resuscitation feedback system (AR-CPR) can support health care providers in delivering high-quality chest compressions during pediatric cardiac arrest. AR-CPR provides real-time visual feedback on chest compression rate, depth, and recoil through a head-mounted augmented reality display. In this randomized, multicenter, international, simulation-based non-inferiority study, health care providers perform chest compressions during an 18-minute simulated pediatric cardiac arrest. Participants are assigned to receive either real-time feedback from AR-CPR or coaching from a trained human CPR coach. The primary objective is to determine whether the percentage of chest compressions meeting guideline targets for both rate and depth with AR-CPR is non-inferior to that achieved with human CPR coaching.
Detailed description
This prospective, multicenter, international, randomized, unblinded, non-inferiority study evaluates an augmented reality cardiopulmonary resuscitation feedback system (AR-CPR) compared with traditional human-delivered quality CPR coaching during simulated pediatric cardiac arrest. The study uses a standardized 18-minute pediatric cardiopulmonary arrest simulation conducted across eight participating institutions in the United States and Canada. Participants are actively credentialed pediatric emergency department or intensive care unit nurses and clinical technicians with current Pediatric Advanced Life Support (PALS) certification and prior experience or training functioning as quality CPR coaches. Participants are organized into teams of one to three members and perform chest compressions on a standardized high-fidelity pediatric manikin during a simulated non-shockable cardiac arrest involving an intubated 7-year-old child. The simulation is limited to chest compression performance to isolate the effect of the feedback modality on CPR quality. Participants are randomized at the team level to one of two study arms. In the control arm, an experienced, trained CPR coach provides real-time, goal-directed feedback based on chest compression rate, depth, and recoil. In the intervention arm, participants use AR-CPR, a head-mounted augmented reality system that provides real-time visual feedback on these same CPR performance measures. AR-CPR displays numerical and visual feedback within the participant's field of view and provides escalating goal-directed guidance when CPR performance falls outside established targets. CPR performance data are collected using the same AR-CPR sensor system in both study arms to provide standardized objective measurement. The study evaluates whether CPR performance with AR-CPR is non-inferior to performance achieved with a trained human CPR coach. The primary measure of CPR performance is the percentage of compressions simultaneously meeting American Heart Association guideline targets for compression rate and depth. Additional assessments characterize other measures of CPR quality and participants' cognitive workload and experience with the augmented reality system.
Interventions
DEVICEAR-CPR
AR-CPR is a real-time augmented reality CPR feedback system designed to guide chest compression performance during pediatric cardiac arrest. The system uses a compression sensor containing an inertial measurement unit (IMU) and force-sensitive resistor (FSR) connected to a microcontroller. Sensor data are relayed to a Raspberry Pi 5 microcomputer running custom AR-CPR Coach software, which calculates chest compression rate, depth, and recoil. These metrics are transmitted wirelessly to a Vuzix M400 head-mounted display. The augmented reality interface provides numerical values and visual cues within the user's field of view. When performance is outside established targets, the system provides qualitative feedback and, for persistent deviations, escalates to explicit goal-directed instructions.
Sponsors
Johns Hopkins University
The Hospital for Sick Children
Columbia University
Brown University
Children's Hospital of Philadelphia
Johns Hopkins All Children's Hospital
Children's Medical Center Dallas
Baylor College of Medicine
Agency for Healthcare Research and Quality (AHRQ)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Actively credentialed pediatric emergency department or pediatric intensive care unit nurse or clinical technician at a participating study site * Current American Heart Association (AHA) Pediatric Advanced Life Support (PALS) certification
Exclusion criteria
* Inability to physically perform chest compressions * Need for prescription corrective lenses without having those corrective lenses available at the time of study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Overall Excellent CPR | Up to 18 minutes | Percentage of chest compressions meeting the study-defined composite criterion for overall excellent CPR. This is a single composite outcome measure in which each chest compression is classified as meeting the outcome only when both compression rate and compression depth simultaneously meet American Heart Association Pediatric Advanced Life Support (AHA PALS) guideline targets. A compression must have both a rate of 100-120 compressions per minute and a depth of 5-6 cm to meet the composite outcome. If either the rate or depth is outside its target range, the compression does not meet the outcome. Rate and depth are therefore not evaluated as separate measurements for this primary outcome; they are simultaneous criteria used to determine whether each compression meets the single composite measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Compressions Meeting Guideline Rate Depth | Up to 18 minutes | Percentage of chest compressions delivered at the AHA PALS guideline-recommended depth of 5-6 cm. Measured during the 18-minute simulated pediatric cardiac arrest. |
| Percentage of Compressions With Adequate Recoil | Up to 18 minutes | Percentage of chest compressions meeting the study-defined criterion for adequate chest recoil. During the 18-minute simulated pediatric cardiac arrest. |
| Percentage of Compressions Meeting Guideline Rate Target | Up to 18 minutes | Percentage of chest compressions delivered at the AHA PALS guideline-recommended rate of 100-120 compressions per minute. Measured during the 18-minute simulated pediatric cardiac arrest. |
| Mean Chest Compression Rate | Up to 18 minutes | Average chest compression rate, measured in compressions per minute, across the full simulated cardiac arrest event. Measured during the 18-minute simulated pediatric cardiac arrest. |
| Mean Chest Compression Depth | Up to 18 minutes | Average chest compression depth, measured in centimeters, across the full simulated cardiac arrest event. Measured during the 18-minute simulated pediatric cardiac arrest. |
| Percentage of Perfect CPR | Up to 18 minutes | Percentage of chest compressions simultaneously meeting study criteria for compression rate, depth, and recoil. Measured during the 18-minute simulated pediatric cardiac arrest. |
Countries
Canada, United States
Contacts
CONTACTKeith Kleinman, MD
CONTACTJustin Jeffers, MD
PRINCIPAL_INVESTIGATORJutin Jeffers, MD
Johns Hopkins University
Outcome results
None listed