A Clinical Trial to Study the Feasibility and Acceptability of an App to Support Pediatric Resuscitation

NCT06768099 | Completed

• 2 other identifiers: 2023P000386R01HL141429
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinicial trial is to test the acceptability and feasibility of linear cognitive aid intervention to support EMS teams in responding to pediatric emergencies. We are testing the hypothesis that cognitive aids with linear logic will be feasible to use and acceptable to EMS teams in urban and rural areas. Researchers will compare technical performance, teamwork, and self-assessed cognitive load of participants to see the difference between performing resuscitations using their current standard with existing cognitive aids and using our linear cognitive aid. Participants' teams will:

• perform in situ high-fidelity simulation of two critical children's resuscitation scenarios
• be randomized to 1) perform both resuscitations with their current standard with existing cognitive aids or 2) perform both resuscitations using our linear cognitive aid.

Conditions

Pediatrics; Emergency Medical Services; Arrest Cardio Respiratory; Pediatric Emergency Medicine; Resuscitation

Keywords

Pediatric emergency medical services; Rural-urban health disparities; Child mortality; Adverse safety events (ASEs); Prehospital pediatric care; Cognitive aid; Randomized controlled trial (RCT); Emergency resuscitation; Out of hospital Cardiac arrest

Outcome Measures

Primary Outcomes (1)

• Time to Achieve AHA Technical Milestones

  Time stamps for achieving completion of clinically recommended steps according to AHA guidance in minutes and seconds over a total 10 min simulation session. Less time taken is better performance.

  10 minute simulation

Secondary Outcomes (2)

• Teamwork

  Cumulative evaluation over each 10 minute simulation

• Cognitive load

  Cumulative evaluation over each 10 minute simulation

Study Arms (2)

Current Standard with Existing Cognitive Aids

NO INTERVENTION

We will perform in situ high-fidelity simulation of two critical children's emergency resuscitation scenarios using the current standard of care with existing cognitive aids.

Linear Cognitive Aid

EXPERIMENTAL

We will perform in situ high-fidelity simulation of two critical children's emergency resuscitation scenarios using a linear cognitive aid

Other: Linear Cognitive Aid

Interventions

Linear Cognitive Aid OTHER

Key features of this tool include: * Minimal input: Teams input the patient's age and clinical scenario (e.g. arrest, childbirth, or trauma). * Linear logic: Based on initial simple input, the tool provides straightforward guidance without requiring multiple Y/N input or advanced decision-making. * Guidance based on individual characteristics: The tool tailors AHA guidance for the specific emergency scenario to the individual patient's size (estimated by age), emphasizing key interventions for the individual scenario and giving appropriate size-based guidance regarding choice of equipment, medication dosage, and resuscitation technique (e.g., chest compression depth). * Time-based and on-demand guidance: Based on the time elapsed from the start of the resuscitation, the app will provide audio guidance regarding the next key steps.

Linear Cognitive Aid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active public, private, volunteer, hospital-based, or third-party EMS providers
• Speaks and understands English
• Age 18 and over

You may not qualify if:

• \- Not clinically active

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

20 Overland 4th floor

Boston, Massachusetts, 02215, United States

Location

BIDMC

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Lee SA, Trujillo D, Meckler GD, Eriksson C, Huynh T, Bahr N, Sanjeevi J, Hansen M, Guise JM. RESCUER mobile app to support pediatric resuscitation: Study protocol for a randomized controlled trial. Contemp Clin Trials Commun. 2025 Oct 8;48:101558. doi: 10.1016/j.conctc.2025.101558. eCollection 2025 Dec.

  PMID: 41142041 DERIVED

MeSH Terms

Conditions

Heart Arrest; Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: We propose to conduct a pilot feasibility randomized control trial of a mobile app that provides AHA cardiac resuscitation guidance. We will perform high-fidelity simulation of two children's resuscitation scenarios. Teams will be randomized to: 1) perform both resuscitations with their current standard with existing cognitive aids or 2) perform both resuscitations using our mobile app. The order of the scenarios will be randomized for each team.

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 10, 2025
• Study Start: February 18, 2025
• Primary Completion: June 5, 2026
• Study Completion: June 5, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)