Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04742426
Status:
UNKNOWN
Last Update Posted:
2021-02-09
First Post:
2021-01-20
Brief Title:
Personal Protective Equipment Affect Team Performance During Medical Emergencies
Sponsor:
Roman Sýkora
Organization:
Charles University Czech Republic
Study Overview
Official Title:
Does the Choice of Personal Protective Equipment Affect Team Performance During Medical Emergencies Simulation-Based Randomised Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PPE-TEAM
Brief Summary:
Safety of healthcare professionals working in high-risk environments is of upmost importance Personal protective equipment PPE may affect the performance of individuals and teams by altering their senses manual skills and ability to communicate Current guidelines offer flexibility in terms of which specific PPE components can safely be used Yet in some organisations healthcare workers become used to using PPE well above the recommended standards termed further in text as super-safe setup SSS Impact of this PPE policy on team performance and in turn to patient safety is unknown The investigators hypothesise that SSS as compared to WHO PPE standard would negatively impact team performance and patient outcomes in a simulated crisis scenario
Detailed Description:
Safety of healthcare professionals working in high-risk environments is of upmost importance Personal protective equipment PPE may affect the performance of individuals and teams by altering their senses manual skills and ability to communicate Current guidelines WHO UK ECDC offer flexibility in terms of which specific PPE components can safely be used Yet in some organisations healthcare workers become used to using PPE well above the recommended standards termed further in text as super-safe setup SSS Impact of this PPE policy on team performance and in turn to patient safety is unknown The investigators hypothesise that SSS as compared to WHO PPE standard would negatively impact team performance and patient outcomes in a simulated crisis scenario
Methods Design prospective open randomised controlled parallel group trial fully compliant with CONSORT guidelines with extension for simulation studies
Study subjects doctors and nurses routinely working in intensive care written prospective informed consent Setting High-fidelity simulation centre Third Faculty of Medicine Charles University in Prague
PPE tested
WHO group CONTROL uses polycarbonate safety spectacles fluid-resistant Type IIR surgical mask and disposable surgical gown One pair of gloves No head or foot cover
SSS group Uses surgical cap FFP3 respirator covered by surgical mask face shield whole-body suit Tyvec 3 pairs of gloves typed to suit sleeves and disposable foot cover
Study procedures Teams consisting of one doctor and two nurses will be recruited The purpose of the study will be explained to them as a part of consent procedure but details of evaluation and scenarios will remain undisclosed All team members will obtain standardized educational materials focused on the solution of airway management and non-shockable rhythm of sudden circulatory arrest in a critically ill patient
Introduction to simulation centre and baseline team performance measurement On the study day the teams will undergo a standardised introduction to simulation centre and perform a mock scenario without PPE apart from gloves and simple surgical masks The same parameters will be measured for mock scenario as for the test scenario
Test scenario This will be a COVID-19 patient on mechanical ventilator who suddenly loses airways and develops profound hypoxia progressing to cardiac arrest Team will be wearing PPE according to their study group allocation at the beginning of the scenario
Outcomes
Primary outcome Non-technical team performance measured as TEAM score and adjusted to baseline team performance
Secondary outcomes Quality of CPR and work according to guidelines
Exploratory qualitative objective physiological functions of team members and self-reported confidence defined on visual analogue scale
Outcome assessment methods Performance indices will be observed by two independent trained assessors Both assessors will have access to video recordings of scenarios and software recordings The final score will be an arithmetic mean of the scores of two observers Inter-rater variability will be calculated and reported
Sample size calculation and statistics According to ref the TEAM performance score was 3307 meanstandard deviation Therefore n22 ie 11 teams per group gives 80 probability of detecting at p005 two sided 25 difference of TEAM scores between groups Primary outcome will be calculated by two sided Student t-test Time-to-event outcomes will be compared using Kaplan-Meier curves and Wilcoxon test
Dissemination plan and implementation Data will be published in a peer-reviewed journal The results have the potential to influence hospital hygiene policies as well as choices made by individual healthcare professionals
Methods Design prospective open randomised controlled parallel group trial fully compliant with CONSORT guidelines with extension for simulation studies
Study subjects doctors and nurses routinely working in intensive care written prospective informed consent Setting High-fidelity simulation centre Third Faculty of Medicine Charles University in Prague
PPE tested
WHO group CONTROL uses polycarbonate safety spectacles fluid-resistant Type IIR surgical mask and disposable surgical gown One pair of gloves No head or foot cover
SSS group Uses surgical cap FFP3 respirator covered by surgical mask face shield whole-body suit Tyvec 3 pairs of gloves typed to suit sleeves and disposable foot cover
Study procedures Teams consisting of one doctor and two nurses will be recruited The purpose of the study will be explained to them as a part of consent procedure but details of evaluation and scenarios will remain undisclosed All team members will obtain standardized educational materials focused on the solution of airway management and non-shockable rhythm of sudden circulatory arrest in a critically ill patient
Introduction to simulation centre and baseline team performance measurement On the study day the teams will undergo a standardised introduction to simulation centre and perform a mock scenario without PPE apart from gloves and simple surgical masks The same parameters will be measured for mock scenario as for the test scenario
Test scenario This will be a COVID-19 patient on mechanical ventilator who suddenly loses airways and develops profound hypoxia progressing to cardiac arrest Team will be wearing PPE according to their study group allocation at the beginning of the scenario
Outcomes
Primary outcome Non-technical team performance measured as TEAM score and adjusted to baseline team performance
Secondary outcomes Quality of CPR and work according to guidelines
Exploratory qualitative objective physiological functions of team members and self-reported confidence defined on visual analogue scale
Outcome assessment methods Performance indices will be observed by two independent trained assessors Both assessors will have access to video recordings of scenarios and software recordings The final score will be an arithmetic mean of the scores of two observers Inter-rater variability will be calculated and reported
Sample size calculation and statistics According to ref the TEAM performance score was 3307 meanstandard deviation Therefore n22 ie 11 teams per group gives 80 probability of detecting at p005 two sided 25 difference of TEAM scores between groups Primary outcome will be calculated by two sided Student t-test Time-to-event outcomes will be compared using Kaplan-Meier curves and Wilcoxon test
Dissemination plan and implementation Data will be published in a peer-reviewed journal The results have the potential to influence hospital hygiene policies as well as choices made by individual healthcare professionals
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None