NCT07778823

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252

participants targeted

Target at P75+ for not_applicable

Timeline
22mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
2 countries

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Jun 2025Jun 2028

Study Start

First participant enrolled

June 29, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

August 26, 2026

Status Verified

August 1, 2026

Enrollment Period

2.8 years

First QC Date

August 17, 2026

Last Update Submit

August 24, 2026

Conditions

Pediatric Cardiac Arrest (Simulated)Cardiac Arrest (CA)Cardiopulmonary Resuscitation (CPR)

Keywords

augmented realitycardiopulmonary resuscitationpediatric cardiac arrestcpr qualitychest compressionscpr coachingreal-time feedbackpediatric advanced life supportsimulation

Outcome Measures

Primary Outcomes (1)

  • Percentage of Overall Excellent CPR

    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.

    Up to 18 minutes

Secondary Outcomes (6)

  • Percentage of Compressions Meeting Guideline Rate Target

    Up to 18 minutes

  • Percentage of Compressions Meeting Guideline Rate Depth

    Up to 18 minutes

  • Percentage of Compressions With Adequate Recoil

    Up to 18 minutes

  • Percentage of Perfect CPR

    Up to 18 minutes

  • Mean Chest Compression Rate

    Up to 18 minutes

  • +1 more secondary outcomes

Study Arms (2)

Quality CPR Coaching

NO INTERVENTION

Participants receive real-time CPR performance feedback from a trained human CPR coach during an 18-minute simulated pediatric cardiac arrest. The CPR coach uses real-time compression rate, depth, and recoil data to provide goal-directed prompts based on Pediatric Advanced Life Support (PALS) targets, positive reinforcement for high-quality CPR, and guidance for compressor changes.

AR-CPR

EXPERIMENTAL

Participants use the AR-CPR system during an 18-minute simulated pediatric cardiac arrest. AR-CPR provides real-time visual feedback on chest compression rate, depth, and recoil through a head-mounted augmented reality display. The system displays numerical values and visual cues and provides goal-directed instructions when CPR performance falls outside established targets.

Device: AR-CPR

Interventions

AR-CPRDEVICE

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.

AR-CPR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Inability to physically perform chest compressions
  • Need for prescription corrective lenses without having those corrective lenses available at the time of study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

All Childrens Hopsital

St. Petersburg, Florida, 33701, United States

RECRUITING

Johns Hopkins Children's Center

Baltimore, Maryland, 21287, United States

RECRUITING

Columbia University Vagelos College of Physicians and Surgeons

New York, New York, 10032, United States

RECRUITING

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Brown/Hasbro Children's Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

University of Texas Southwestern Medical center/ Children's Health of Dallas

Dallas, Texas, 75235, United States

RECRUITING

Texas Childrens

Houston, Texas, 77030, United States

RECRUITING

The hospital for sick children

Toronto, Ontario, Canada

RECRUITING

Related Publications (3)

  • Kleinman K, Dean JL, Yu E, Schreurs BA, Jeffers JM. AR-CPR 2.0: Validation of the Accuracy and Precision of a Wearable Coaching System for Improving Chest Compression Performance. J Med Device. 2025 Feb 1;20(1):011007. doi: 10.1115/1.4070016. Epub 2025 Nov 27.

    PMID: 41480194BACKGROUND

  • Kleinman K, Hairston T, Smith B, Billings E, Tackett S, Chopra E, Risko N, Swedien D, Schreurs BA, Dean JL, Scott B, Canares T, Jeffers JM. Pediatric Chest Compression Improvement Via Augmented Reality Cardiopulmonary Resuscitation Feedback in Community General Emergency Departments: A Mixed-Methods Simulation-Based Pilot Study. J Emerg Med. 2023 Jun;64(6):696-708. doi: 10.1016/j.jemermed.2023.03.058. Epub 2023 Mar 22.

    PMID: 37438023BACKGROUND

  • Jeffers JM, Schreurs BA, Dean JL, Scott B, Canares T, Tackett S, Smith B, Billings E, Billioux V, Sampathkumar HD, Kleinman K. Paediatric chest compression performance improves via novel augmented-reality cardiopulmonary resuscitation feedback system: A mixed-methods pilot study in a simulation-based setting. Resusc Plus. 2022 Jul 9;11:100273. doi: 10.1016/j.resplu.2022.100273. eCollection 2022 Sep.

    PMID: 35844631BACKGROUND

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Jutin Jeffers, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Keith Kleinman, MD

CONTACT

410-955-5000kkleinm3@jh.edu

Justin Jeffers, MD

CONTACT

410-955-5000jjeffers@jhmi.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2026

First Posted

August 21, 2026

Study Start

June 29, 2025

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

August 26, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be publicly shared because the study involves a relatively small, specialized population of healthcare providers recruited from a limited number of participating institutions, which may increase the risk of participant identification. Aggregate and de-identified study results will be reported in scientific publications and presentations.

Locations

US(7)CA(1)