Rational Use of Personal Protective Equipment During COVID-19 Pandemic (RUPERT)

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.

Study Overview

• Status: Completed
• Conditions: Covid19; Personal Protective Equipment
• Intervention / Treatment: Other: New PPE; Other: Old PPE

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
      • Professor Peter McCulloch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. NHS staff and works in the Adult Intensive Care Unit, Neuro Intensive Care Unit or Cardio-thoracic Intensive Care Unit
2. Trained in the correct use of Level 2 PPE according to current guidance
3. Trained in ICU COVID19 Intubation and Proning protocols
4. 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Oxford
• Investigators: Principal Investigator: Peter McCulloch, University of Oxford

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): December 12, 2020
• Study Completion (Actual): December 12, 2020

Study Registration Dates

• First Submitted: January 11, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: PPE; Multi-drug resistance organism; Cross-infection
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: IRAS287865

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No