Transference of Established Simulated Skills (TEST) Trial (TEST)

March 22, 2026 updated by: Vishal Kapadia, University of Texas Southwestern Medical Center

Transference of Established Simulated Skills (TEST) Trial: Tracking Transference of Positive Pressure Ventilation Skills From Simulation to Delivery Room.

This study aims to determine if skills learned in the simulation lab, specifically in managing mask leak during positive pressure ventilation (PPV), translate effectively to the delivery room. By comparing the performance of healthcare providers on mannequins in the lab to their performance on newborns in the delivery room, the study seeks to establish a Ventilation Performance Score (VPS) based on data from a respiratory function monitor. The primary hypothesis is that a provider's ability to minimize mask leak on a mannequin correlates with their ability to do so with a newborn. The prospective observational TEST Trial will use the Monivent Neo100 to collect and analyze PPV data, comparing key parameters like mask leak and VQS between the two settings to assess correlations. Secondary analysis will explore individual aspects of PPV, such as PIP, PEEP, and eVT.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Objectives: The aim of this study is to establish evidence that supports the transfer of skills learned in the simulation lab to the delivery room. The objective of this study is to compare the performance of positive pressure ventilation (PPV) in the simulation lab to the performance of the same individual in the delivery room. Our goal is to establish a comparison between parameters measured on the simulator and those obtained from real newborn infants, specifically looking at mask leak. Our approach hopes to develop a ventilation performance score (VPS) in the process that will be based on objective data collected using a respiratory function monitor (RFM). The primary hypothesis is that the quality of a qualified provider's ability to circumvent mask leak on a mannequin correlates with the ability of the same provider to circumvent mask leak observed on a newborn infant.

Design and outcomes: TEST Trial is a prospective observational study to assess differences in the participants ability to avoid mask leak while performing PPV and in the process allow the investigators to develop a ventilatory performance score in the simulation lab and the delivery room. We will use the RFM Monivent Neo100 to gather PPV data in both the simulation lab from the mannequins and newborns in the delivery room. The study will compare mask leak as well as VPS in the simulation room to mask leak and VPS in the delivery room to assess for correlations. In addition, the investigators will conduct secondary analysis on each individual domain of positive pressure ventilation, such as PIP, PEEP, eVT, etc.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75235
        • Parkland Memorial Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

  1. Respiratory Therapists (RTs):

    Demographics: This group includes Respiratory Therapists employed in the Neonatal Intensive Care Unit (NICU) at Parkland Hospital. Participants have varying levels of experience, ranging from newly certified RTs to those with extensive experience in neonatal care.

  2. Newborn Infants:

Demographics: This group includes newborn infants requiring positive pressure ventilation (PPV) immediately after birth in the delivery room. Infants included in the study will vary in gestational age, birth weight, and clinical condition, representing a broad range of neonatal resuscitation scenarios.

Description

Inclusion and Exclusion Criteria for Respiratory Therapists (RTs)

Inclusion Criteria:

  • Respiratory Therapists who are employed in the Neonatal Intensive Care Unit (NICU) at Parkland Hospital.
  • RTs who actively participate in neonatal deliveries.

Exclusion Criteria:

  • Respiratory Therapists classified as "float" RTs, meaning those who do not have a permanent assignment in the NICU.
  • RTs who intend to leave the institution within the upcoming year.

Inclusion and Exclusion Criteria for Newborn Infants

Inclusion Criteria:

  • Newborn infants who require positive pressure ventilation (PPV) immediately after birth in the delivery room.
  • Infants of various gestational ages and birth weights, representing a broad spectrum of neonatal resuscitation scenarios.

Exclusion Criteria:

  • Newborns who do not require PPV after birth.
  • Infants for whom the use of the respiratory function monitor (RFM) is not feasible due to medical or technical reasons.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Respiratory Therapists
This cohort consists of respiratory therapists (RTs) who are actively involved in both simulation-based training sessions and actual neonatal deliveries. Participants will have varying levels of experience, from newly qualified to seasoned professionals. During the study, RTs will perform positive pressure ventilation (PPV) on both neonatal mannequins in the simulation lab and on newborns in the delivery room. Their performance will be measured using a respiratory function monitor (RFM), focusing on parameters such as mask leak, peak inspiratory pressure (PIP), positive end-expiratory pressure (PEEP), and exhaled tidal volume (eVT). The goal is to assess the transferability of their skills from simulation to real-life scenarios.
Behavioral: Simulation
Observational study with simulations.
Newborn Infants
This cohort consists of respiratory therapists (RTs) who are actively involved in both simulation-based training sessions and actual neonatal deliveries. Participants will have varying levels of experience, from newly qualified to seasoned professionals. During the study, RTs will perform positive pressure ventilation (PPV) on both neonatal mannequins in the simulation lab and on newborns in the delivery room. Their performance will be measured using a respiratory function monitor (RFM), focusing on parameters such as mask leak, peak inspiratory pressure (PIP), positive end-expiratory pressure (PEEP), and exhaled tidal volume (eVT). The goal is to assess the transferability of their skills from simulation to real-life scenarios.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Correlation of mask leak performance
Time Frame: 1 year
Correlation between the percentage of mask leak observed during positive pressure ventilation (PPV) on a mannequin in the simulation laboratory and the percentage of mask leak observed during PPV on a newborn infant in the delivery room.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation of Ventilation Performance Score (VPS)
Time Frame: 1 year
Correlation of Ventilation Performance Score (VPS) between the simulation lab and the delivery room.
1 year
Correlation of submetrics of VPS
Time Frame: 1 year
Correlation of submetrics of VPS (such as TVe, mask seal, PIP, PEEP, etc.) between the simulation lab and the delivery room.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Texas Southwestern Medical Center

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.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 12, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 29, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 29, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STU 2023-1099

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Neonatal Respiratory Distress

Clinical Trials on Simulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings