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Completed

NCT Number: NCT06768099

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

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.

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Key information

Conditions

Pediatric Emergency Medicine Arrest Cardio Respiratory Cardiovascular Diseases Emergency Medical Services Heart Arrest Heart Diseases Out-of-Hospital Cardiac Arrest Pediatrics Resuscitation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

20 Overland 4th floor, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Not clinically active

Treatment and study plan

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.

Primary outcomes

  1. Time to Achieve AHA Technical Milestones

    Time frame: 10 minute simulation

    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.

Secondary outcomes

  1. Teamwork

    Time frame: Cumulative evaluation over each 10 minute simulation

    Teamwork will be evaluated in real time using the validated Clinical Teamwork Scale (CTS™) over each 10 minute simulation. The scale ranges from 0 to 10, with 0 being "unacceptable" and 10 being "perfect."

  2. Cognitive load

    Time frame: Cumulative evaluation over each 10 minute simulation

    Cognitive load will be self-assessed after each 10 minute simulation, using the NASA-TLX, a previously validated and widely used tool that measures mental, physical, and temporal demand, overall performance, effort, and frustration level to create an overall task load index for each team member. The scale has a range of 0 to 100 with a higher score indicating higher cognitive load.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Reducing Disparities for Children in Rural Emergency Resuscitation (RESCU-ER): Developing and Testing the Acceptability and Feasibility of an Integrated Linear Cognitive Aid for Pediatric Resuscitation in a Pilot RCT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 10, 2025
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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