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Completed

NCT Number: NCT04712045

Rational Use of Personal Protective Equipment 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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Cross Infection Disease Attributes Iatrogenic Disease Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Personal Protective Equipment Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Professor Peter McCulloch

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • taking any medication which can cause photosensitivity reactions in the preceding 3 months

Treatment and study plan

New PPE

Other

The use of a new protocol of level 2 PPE which involves wearing a short-sleeve gown and a single pair of gloves

Old PPE

Other

The use of a standard protocol of level 2 PPE which involves wearing a long-sleeve gown and double pairs of gloves

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    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

  2. 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

    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.

  3. The difference in the area of contamination between New and Standard PPE as analyzed through python script

    Time frame: immediately after simulations

    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.

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study title

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

Acronym: RUPERT

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 15, 2021
Registry last updated
Jan 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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