NCT07307573

Brief Summary

The purpose of this study is to study and compare the efficacy and feasibility of a remotely supported simulation-based procedural curriculum for Emergency Medical Services (EMS) clinicians.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
133

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

June 14, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 29, 2025

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

December 23, 2025

Last Update Submit

December 26, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • intraosseous (IO) catheterization procedural outcome score

    The IO assessment tool was adapted from a previously validated simulation assessment tool. The score ranged from 0-12, with higher score demonstrating better performance. Participants submitted videos for review, which were scored by trained video reviewers using the assessment tool based on a corresponding data dictionary. Scores were then aggregated for analysis.

    participants submitted 1-2 procedural videos based on training date during the 1-year study period

  • bag valve mask (BVM) ventilation procedural outcome score

    The BVM assessment tool was adapted from a previously validated simulation assessment tool. The score ranged from 0-12, with higher score demonstrating better performance. Participants submitted videos for review, which were scored by trained video reviewers using the assessment tool based on a corresponding data dictionary. Scores were then aggregated for analysis.

    participants submitted 1-2 procedural videos based on training date during the 1-year study period

  • supraglottic device (SGD) placement procedural outcome score

    The SGD assessment tool was modified from a prior psychomotor examination checklist used by the National Registry of Emergency Medical Technicians. The score ranged from 0-14, with higher score demonstrating better performance. Participants submitted videos for review, which were scored by trained video reviewers using the assessment tool based on a corresponding data dictionary. Scores were then aggregated for analysis.

    participants submitted 1-2 procedural videos based on training date during the 1-year study period

Secondary Outcomes (1)

  • qualitative feedback regarding the curriculum

    1 year study period

Study Arms (1)

educational intervention

EXPERIMENTAL

received training and submitted video on each procedure

Behavioral: education

Interventions

educationBEHAVIORAL

pediatric emergency care coordinator provided education on each procedure performed

educational intervention

Eligibility Criteria

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

You may qualify if:

  • all full-time or part-time EMS clinicians at the recruited agencies with BVM ventilation, SGD placement, and/or IO catheterization within their scope of practice

You may not qualify if:

  • no procedures of interest within scope of practice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

  • Lee SH, Riney LC, Merkt B, McDonough SD, Baker J, Boyd S, Zhang Y, Geis GL. Improving Pediatric Procedural Skills for EMS Clinicians: A Longitudinal Simulation-Based Curriculum with Novel, Remote, First-Person-View Video-Based Outcome Measurement. Prehosp Emerg Care. 2024;28(2):352-362. doi: 10.1080/10903127.2023.2263555. Epub 2024 Feb 1.

    PMID: 37751212BACKGROUND

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Sang Hoon Lee

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: all participants received the same educational intervention
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2025

First Posted

December 29, 2025

Study Start

June 14, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations