Rational Use of Personal Protective Equipment During COVID-19 Pandemic

Study Overview
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Brief Summary
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This study aims to improve the personal protective equipment (PPE) used while treating patients with COVID-19, to protect staff and avoid cross-infection of patients. Protecting staff from infection during the Covid pandemic is critical to maintaining health services. Mistakes in using protective equipment (PPE) are the commonest avoidable factor in staff becoming infected at work. Recently, intensive care doctors have also reported an increase in the spread of dangerous multi-resistant bacteria between patients, which appears likely to be transmitted between patients by Level 2 PPE worn by staff (specifically gown sleeves). This study therefore seeks to develop and test a new protocol to decrease cross-infection risks whilst using Level 2 PPE.

Official Title
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Rational Use of Personal Protective Equipment: a Randomised Trial and Quality Improvement Intervention During COVID-19 Pandemic

Conditions
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Covid19, Personal Protective Equipment

Intervention / Treatment
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* Other: New PPE
* Other: Old PPE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: NHS staff and works in the Adult Intensive Care Unit, Neuro Intensive Care Unit or Cardio-thoracic Intensive Care Unit Trained in the correct use of Level 2 PPE according to current guidance Trained in ICU COVID19 Intubation and Proning protocols Willing and able to give informed consent for participation in the study. Exclusion Criteria: 1. taking any medication which can cause photosensitivity reactions in the preceding 3 months
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New PPE<br>Use of Short sleeve gown and single pair of gloves | Other: New PPE<br>* The use of a new protocol of level 2 PPE which involves wearing a short-sleeve gown and a single pair of gloves<br>|
| Active Comparator: Old PPE<br>Use of Long sleeve gown and double pairs of gloves | Other: Old PPE<br>* The use of a standard protocol of level 2 PPE which involves wearing a long-sleeve gown and double pairs of gloves<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants and simulated patients with contamination as assessed by ultraviolet light | The primary outcome of this study is the proportion of participants and simulated patients who were contaminated with fluorescent powder as examined under a UV light, using a response of YES or NO, when participants wore new (experimental) Level 2 PPE in comparison to the standard (control) Level 2 PPE | immediately after simulations | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants' perception of personal comfort and safety and safety of the patients as assessed through structured questionnaire | We will measure the participants' perception of personal comfort and safety and the safety of the patient when wearing experimental versus control Level 2 PPE, during simulation tasks, using a 10 point Likert scale response to a structured questionnaire | immediately before simulations and immediately after simulations | 
| changes in participants perception of personal comfort and safety and safety of patients as assessed through a semi-structured questionnaire | We will measure changes in participants perception of their personal comfort and safety and the safety of patients when wearing each type of PPE using a semi-structured interview (a) before the PPE training, (b) after the PPE training, and (c) after the simulation training exercises. | immediately before training, immediately after training and immediately after simulation | 
| The difference in the area of contamination between New and Standard PPE as analyzed through python script | we will perform a quantitative analysis of the area of contamination of participants and simulated patients and assess the difference between when participants wore new (experimental) Level 2 PPE and the standard (control) Level 2 PPE, using pre-coded functions with python script. | immediately after simulations | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PPE, Multi-drug resistance organism, Cross-infection