Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572033
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Transference of Established Simulated Skills TEST Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Transference of Established Simulated Skills TEST Trial Tracking Transference of Positive Pressure Ventilation Skills From Simulation to Delivery Room
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEST
Brief 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 providers 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
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 providers 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None