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

Not Applicable

Recruiting

• Conditions: Pediatric Emergency Medicine; Resuscitation; Pediatrics; Emergency Medical Services; Arrest Cardio Respiratory

• Registration Number: NCT06768099
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-30
• Study First Submitted QC: 2025-01-06
• Study Start: 2025-02-18
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01
• Primary Completion: 2025-12
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to Achieve AHA Technical Milestones	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 Outcome Measures

Name	Time	Method
Teamwork	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."
Cognitive load	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.

Trial Locations

Locations (2)

20 Overland 4th floor; 🇺🇸 Boston, Massachusetts, United States

BIDMC; 🇺🇸 Boston, Massachusetts, United States