- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07307573
A Remotely Supported Pediatric Simulation-Based Procedural Training Curriculum for EMS Clinicians
December 26, 2025 updated by: Children's Hospital Medical Center, Cincinnati
A Remotely Supported Pediatric Simulation-Based Procedural Training Curriculum for EMS Clinicians: Partnering PECCs and Pediatric Experts at a Distance
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study transitioned a previously reported, traditional, simulation-based training curriculum delivered by on-site pediatric simulation experts, into a program delivered by agency Pediatric Emergency Care Coordinators (PECCs) supported by remote pediatric experts.
The PECCs delivered the curriculum on site, and submitted first-person-view videos captured using a head-mounted camera of three procedures (bag-valve mask [BVM] ventilation, supraglottic device [SGD] insertion, and intraosseous [IO] catheterization) to pediatric education experts who provided scoring and feedback to the participants.
The team tracked scores for all three procedures during the study period, compared scores to the previous study's, and solicited feedback from the PECCs and participants regarding these educational methods.
Study Type
Interventional
Enrollment (Actual)
133
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- no procedures of interest within scope of practice
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: educational intervention
received training and submitted video on each procedure
|
pediatric emergency care coordinator provided education on each procedure performed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
intraosseous (IO) catheterization procedural outcome score
Time Frame: participants submitted 1-2 procedural videos based on training date during the 1-year study period
|
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
Time Frame: participants submitted 1-2 procedural videos based on training date during the 1-year study period
|
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
Time Frame: participants submitted 1-2 procedural videos based on training date during the 1-year study period
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
qualitative feedback regarding the curriculum
Time Frame: 1 year study period
|
Feedback regarding the curriculum and educational experience was solicited via e-mail from participants at time of score reporting.
Similar feedback was solicited via e-mail from educators throughout the study period during scheduling or troubleshooting correspondences.
Comments were tabulated and summarized.
|
1 year study period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sang Hoon Lee, Children's Hospital Medical Center, Cincinnati
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 14, 2021
Primary Completion (Actual)
June 30, 2022
Study Completion (Actual)
June 30, 2022
Study Registration Dates
First Submitted
December 23, 2025
First Submitted That Met QC Criteria
December 26, 2025
First Posted (Actual)
December 29, 2025
Study Record Updates
Last Update Posted (Actual)
December 29, 2025
Last Update Submitted That Met QC Criteria
December 26, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-0172
- 2UL1TR001425-05A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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