Safety IssuesPPE-TEAMNCT04742426
Personal Protective Equipment Affect Team Performance During Medical Emergencies
A study testing WHO recommended PPE and Super-safe setup in people with Safety Issues and Communication, run by Roman Sýkora.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety Issues, Communication, Cardiopulmonary Arrest
- What is being tested?
- WHO recommended PPE and Super-safe setup
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not giving or withdrawal of the informed consent
- Not willing to participate
- Incomplete data acqusition
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Does the Choice of Personal Protective Equipment Affect Team Performance During Medical Emergencies? Simulation-Based Randomised Controlled Trial
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.
Read the 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 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.
- Conditions
- Safety Issues, Communication, Cardiopulmonary Arrest
- Being tested
- WHO recommended PPE, Super-safe setup
- Keywords
- Personal Protective Equipment, Simulation Study, Cardiopulmonary Resuscitation, Non-Technical Skills
- Medical subject headings
- Communication, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHO recommended PPEOther
Uses polycarbonate safety spectacles, fluid-resistant (Type IIR) surgical mask and disposable surgical gown. No head or foot cover.
Super-safe setupOther
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 group | Role | What they receive |
|---|---|---|
| WHO group | Active comparator | minimal setting of personal protective equipment (COVID 19) recommended by WHO Receives: Other: WHO recommended PPE |
| Super-safe setup | Experimental | maximal super-safe setup of personal protective equipment Receives: Other: Super-safe setup |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the intervention
Secondary outcomes (5)
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.
Measured: During the intervention
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.
Measured: During the intervention
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.
Measured: During the intervention
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.
Measured: During the intervention
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.
Measured: During the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start1 May 2021 (estimated)
- Primary completion31 Aug 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-center, randomized (1:1), parallel-group, simulation study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roman Sýkora
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Roman Sýkora, Charles University, Czech Republic
- Investigators
- Frantisek Duska, PhD, Study director, Third Medical Faculty and FNKV University Hospital, Charles University in Prague, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742426
- Sponsor's protocol ID
- PPE-TEAM
- Acronym
- PPE-TEAM
- Status last verified
- Feb 2021
- First submitted
- 20 Jan 2021
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data, forms, consents and protocols will be provided on reasonable request by investigators.
Publications
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 Dec 1;16(6):e200-e205. doi: 10.1097/SIH.0000000000000540.
PubMed 33428358Cooper 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.2009.11.027. Epub 2010 Feb 1.
PubMed 20117874
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Choice of Personal Protective Equipment Affect Team Performance During Medical Emergencies? Simulation-Based Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04742426
- Acronym / sponsor ID
- PPE-TEAM / PPE-TEAM
- Conditions
- Safety Issues, Communication, Cardiopulmonary Arrest
- Keywords
- Personal Protective Equipment, Simulation Study, Cardiopulmonary Resuscitation, Non-Technical Skills
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Roman SýkoraUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- single-center, randomized (1:1), parallel-group, simulation study
| Arm | Type | Receives |
|---|---|---|
| WHO group | Active comparator | Other: WHO recommended PPEminimal setting of personal protective equipment (COVID 19) recommended by WHO |
| Super-safe setup | Experimental | Other: Super-safe setupmaximal super-safe setup of personal protective equipment |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Not giving or withdrawal of the informed consent
- Not willing to participate
- Incomplete data acqusition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WHO recommended PPEUses polycarbonate safety spectacles, fluid-resistant (Type IIR) surgical mask and disposable surgical gown. No head or foot cover. | Other | WHO group |
| Super-safe setupUses 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. | Other | Super-safe setup |
Primary outcome
The Team Emergency Assessment Measure score (TEAM score)
Time frame: During the intervention
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.
5 secondary outcomes
Time to first chest compression
Time frame: During the intervention
Time to first epinephrine dose administration
Time frame: During the intervention
Time to first effective breath after reintubation
Time frame: During the intervention
Chest compression frequency
Time frame: During the intervention
Chest compression depth
Time frame: During the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Results publication: PubMed 33428358Mormando 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 Dec 1;16(6):e200-e205. doi: 10.1097/SIH.0000000000000540.
- Results publication: PubMed 20117874Cooper 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.2009.11.027. Epub 2010 Feb 1.
- Individual participant dataSharing planned: No. All data, forms, consents and protocols will be provided on reasonable request by investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frantisek Duska, PhD study director
Third Medical Faculty and FNKV University Hospital, Charles University in Prague, Czech Republic
Questions about this trial
What is this clinical trial studying?
A study testing WHO recommended PPE and Super-safe setup in people with Safety Issues and Communication, run by Roman Sýkora.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roman Sykora, PhD (+420602524203, roman.sykora@lf3.cuni.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Team Emergency Assessment Measure score (TEAM score) (time frame: During the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04742426, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.