Personal Protective Equipment Affect Team Performance During Medical Emergencies

Safety Issues Clinical Trial

— PPE-TEAM  

Official title:

Does the Choice of Personal Protective Equipment Affect Team Performance During Medical Emergencies? Simulation-Based Randomised Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04742426
• Other study ID #: PPE-TEAM
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: February 2021
• Source: Charles University, Czech Republic
• Contact: Roman Sykora, PhD
• Phone: +420602524203
• Email: roman.sykora[@]lf3.cuni.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 3.3±0.7 (mean±standard deviation). Therefore, n=22 (i.e. 11 teams per group) gives 80% probability of detecting at p<0.05 (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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: September 30, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Emergency Medicine (EM) and Anesthesiology and Critical Care (ACC) physicians

• Emergency Medicine (EM) and Anesthesiology and Critical Care (ACC) nurses

• Preparation and study of sent educational materials

• Fulfillment of the whole complete simulation

Exclusion Criteria:

• Not giving or withdrawal of the informed consent

• Not willing to participate

• Incomplete data acqusition

Related Conditions & MeSH terms

• Cardiopulmonary Arrest
• Communication
• Emergencies
• Heart Arrest
• Safety Issues

Intervention

Other:
• WHO recommended PPE
Uses polycarbonate safety spectacles, fluid-resistant (Type IIR) surgical mask and disposable surgical gown. No head or foot cover.
• Super-safe setup
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Roman Sýkora

References & Publications (2)

Cooper S, Cant R, Porter J, Sellick K, Somers G, Kinsman L, Nestel D. Rating medical emergency teamwork performance: development of the Team Emergency Assessment Measure (TEAM). Resuscitation. 2010 Apr;81(4):446-52. doi: 10.1016/j.resuscitation.2009.11.02 — View Citation

Mormando G, Paganini M, Alexopoulos C, Savino S, Bortoli N, Pomiato D, Graziano A, Navalesi P, Fabris F. Life-Saving Procedures Performed While Wearing CBRNe Personal Protective Equipment: A Mannequin Randomized Trial. Simul Healthc. 2021 Jan 8;Publish Ah — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood pressure of team members	Blood pressure of all the team members will be monitored in two minutes intervals throughout the simulation.	During the intervention
Other	Heart rate of team members	Heart rate of all the team members will be monitored continuously throughout the simulation.	During the intervention
Other	Breathing frequency	The breathing frequency will be measured in all the team members in resting condition and than continuously throughout the simulation.	During the intervention
Other	Body temperature of team members	Blood temperature of all the team members will be measured in resting condition and at the end of the simulated scenario.	Immediately after the intervention
Other	Self assessment of the team performance	The self assessment of the team performance by all the teams members will be obtained. The score will be evaluated by the team members from one to ten points, where ten points indicate the best possible performance.	Immediately after the intervention
Primary	The Team Emergency Assessment Measure score (TEAM score)	The TEAM questionaire will be used and will address following items: 1) the team leader let the team know what was expected of them through direction and command, 2) the team leader maintained a global perspective, 3) the team communicated effectively, 4) the team worked together to complete tasks in a timely manner, 5) the team acted with composure and control, 6) the team morale was positive, 7)the team adapted to changing situations, 8) the team monitored and reassessed the situation, 9) the team anticipated potential actions, 10) the team prioritized tasks, 11) the team followed approved standards/guidelines and 12) the global score. The TEAM items 1 - 11 will be rated using a five-point scale (range 0-4; 0 never/hardly ever, 1 seldom, 2 about as often as not, 3 often, 4 always/nearly always). The item 12 (global score) - the overall performance will be rated on scale from 1 to 10 (best). The mean for each item will be calculated.	During the intervention
Secondary	Time to first chest compression	Time to first chest compression from the start of the scenario will be measured in seconds. Time will be obtained from the software recording of the simulator as time to first compression to reach depth at least 5cm.	During the intervention
Secondary	Time to first epinephrine dose administration	The time to to first epinephrine dose administration (seconds) will be measured by observer and checked from the simulator recording.	During the intervention
Secondary	Time to first effective breath after reintubation	The time to perform the first effective breath (tidal volume of at least 400ml) after reintubation will be measured in seconds . The time will be obtained from the software recording of the simulator.	During the intervention
Secondary	Chest compression frequency	Average chest compression rate (per minute) will be calculated from from the software recording of the simulator. In addition, the percentage of time out of the total compression time, when the frequency of 100-120 per minute was reached, will be measured.	During the intervention
Secondary	Chest compression depth	Average chest compression depth (cm) will be obtained from the software recording of the simulator. In addition, the percentage of compressions reaching a depth of 5 - 6 cm from the total number of compressions will be calculated.	During the intervention