Rational Use of Personal Protective Equipment During COVID-19 Pandemic (RUPERT)
Primary Purpose
Covid19, Personal Protective Equipment
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
New PPE
Old PPE
Sponsored by
About this trial
This is an interventional prevention trial for Covid19 focused on measuring PPE, Multi-drug resistance organism, Cross-infection
Eligibility Criteria
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
Sites / Locations
- Professor Peter McCulloch
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
New PPE
Old PPE
Arm Description
Use of Short sleeve gown and single pair of gloves
Use of Long sleeve gown and double pairs of gloves
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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.
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.
Full Information
NCT ID
NCT04712045
First Posted
January 11, 2021
Last Updated
January 13, 2021
Sponsor
University of Oxford
1. Study Identification
Unique Protocol Identification Number
NCT04712045
Brief Title
Rational Use of Personal Protective Equipment During COVID-19 Pandemic
Acronym
RUPERT
Official Title
Rational Use of Personal Protective Equipment: a Randomised Trial and Quality Improvement Intervention During COVID-19 Pandemic
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
December 12, 2020 (Actual)
Study Completion Date
December 12, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oxford
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Personal Protective Equipment
Keywords
PPE, Multi-drug resistance organism, Cross-infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
New PPE
Arm Type
Experimental
Arm Description
Use of Short sleeve gown and single pair of gloves
Arm Title
Old PPE
Arm Type
Active Comparator
Arm Description
Use of Long sleeve gown and double pairs of gloves
Intervention Type
Other
Intervention Name(s)
New PPE
Intervention Description
The use of a new protocol of level 2 PPE which involves wearing a short-sleeve gown and a single pair of gloves
Intervention Type
Other
Intervention Name(s)
Old PPE
Intervention Description
The use of a standard protocol of level 2 PPE which involves wearing a long-sleeve gown and double pairs of gloves
Primary Outcome Measure Information:
Title
Proportion of participants and simulated patients with contamination as assessed by ultraviolet light
Description
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
Time Frame
immediately after simulations
Secondary Outcome Measure Information:
Title
Participants' perception of personal comfort and safety and safety of the patients as assessed through structured questionnaire
Description
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
Time Frame
immediately before simulations and immediately after simulations
Title
changes in participants perception of personal comfort and safety and safety of patients as assessed through a semi-structured questionnaire
Description
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.
Time Frame
immediately before training, immediately after training and immediately after simulation
Title
The difference in the area of contamination between New and Standard PPE as analyzed through python script
Description
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.
Time Frame
immediately after simulations
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter McCulloch
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
Professor Peter McCulloch
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Rational Use of Personal Protective Equipment During COVID-19 Pandemic
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