Transference of Established Simulated Skills (TEST) Trial (NCT06572033) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Transference of Established Simulated Skills (TEST) Trial
United States120 participantsStarted 2024-08-12
Plain-language summary
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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation of mask leak performance
Timeframe: 1 year
Trial details
NCT IDNCT06572033
SponsorUniversity of Texas Southwestern Medical Center