Covid19RUPERTNCT04712045
Rational Use of Personal Protective Equipment During COVID-19 Pandemic
A study testing New PPE and Old PPE in people with Covid19 and Personal Protective Equipment, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Covid19, Personal Protective Equipment
- What is being tested?
- New PPE and Old PPE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2020to 12 Dec 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1. taking any medication which can cause photosensitivity reactions in the preceding 3 months
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Professor Peter McCulloch
Oxford, Oxfordshire, OX3 9DU
About this study
Official title: Rational Use of Personal Protective Equipment: a Randomised Trial and Quality Improvement Intervention During COVID-19 Pandemic
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.
- Conditions
- Covid19, Personal Protective Equipment
- Being tested
- New PPE, Old PPE
- Keywords
- PPE, Multi-drug resistance organism, Cross-infection
- Medical subject headings
- COVID-19, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New PPEOther
The use of a new protocol of level 2 PPE which involves wearing a short-sleeve gown and a single pair of gloves
Old PPEOther
The use of a standard protocol of level 2 PPE which involves wearing a long-sleeve gown and double pairs of gloves
| Study group | Role | What they receive |
|---|---|---|
| New PPE | Experimental | Use of Short sleeve gown and single pair of gloves Receives: Other: New PPE |
| Old PPE | Active comparator | Use of Long sleeve gown and double pairs of gloves Receives: Other: Old PPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: immediately after simulations
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: immediately after simulations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start1 Aug 2020
- Primary completion12 Dec 2020
- Study completion12 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ProfessorPeterMcculloch, University of Oxford
- Investigators
- Peter McCulloch, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712045
- Sponsor's protocol ID
- IRAS287865
- Acronym
- RUPERT
- Status last verified
- Jan 2021
- First submitted
- 11 Jan 2021
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rational Use of Personal Protective Equipment: a Randomised Trial and Quality Improvement Intervention During COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04712045
- Acronym / sponsor ID
- RUPERT / IRAS287865
- Conditions
- Covid19, Personal Protective Equipment
- Keywords
- PPE, Multi-drug resistance organism, Cross-infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 12 Dec 2020 (actual)
- Study completion
- 12 Dec 2020 (actual)
- First posted
- 15 Jan 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New PPE | Experimental | Other: New PPEUse of Short sleeve gown and single pair of gloves |
| Old PPE | Active comparator | Other: Old PPEUse of Long sleeve gown and double pairs of gloves |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. taking any medication which can cause photosensitivity reactions in the preceding 3 months
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 |
|---|---|---|
| New PPEThe use of a new protocol of level 2 PPE which involves wearing a short-sleeve gown and a single pair of gloves | Other | New PPE |
| Old PPEThe use of a standard protocol of level 2 PPE which involves wearing a long-sleeve gown and double pairs of gloves | Other | Old PPE |
Primary outcome
Proportion of participants and simulated patients with contamination as assessed by ultraviolet light
Time frame: immediately after simulations
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
3 secondary outcomes
Participants' perception of personal comfort and safety and safety of the patients as assessed through structured questionnaire
Time frame: 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
Time frame: 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
Time frame: immediately after simulations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Peter McCulloch principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New PPE and Old PPE in people with Covid19 and Personal Protective Equipment, run by University of Oxford at 1 site in United Kingdom.
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 1 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: finished, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants and simulated patients with contamination as assessed by ultraviolet light (time frame: immediately after simulations). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2021.