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

NCT ID: NCT06768099

Last Updated: 2025-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-18

Study Completion Date

2026-03-31

Brief Summary

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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

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Conditions

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Pediatric Emergency Medicine Resuscitation Pediatrics Emergency Medical Services Arrest Cardio Respiratory

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Current Standard with Existing Cognitive Aids

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Linear Cognitive Aid

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

Group Type EXPERIMENTAL

Linear Cognitive Aid

Intervention Type 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.

Interventions

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Linear Cognitive Aid

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jeanne-Marie Guise

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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20 Overland 4th floor

Boston, Massachusetts, United States

Site Status RECRUITING

BIDMC

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jeanne-Marie Guise, MD, MPH, MBA

Role: CONTACT

617-667-4130

References

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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.

Reference Type DERIVED
PMID: 41142041 (View on PubMed)

Other Identifiers

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R01HL141429

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2023P000386

Identifier Type: -

Identifier Source: org_study_id

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