Rational Use of Personal Protective Equipment During COVID-19 Pandemic

Covid19 Clinical Trial

— RUPERT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04712045
• Other study ID #: IRAS287865
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: December 12, 2020

Study information

• Verified date: January 2021
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 12, 2020
• Est. primary completion date: December 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Personal Protective Equipment

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Professor Peter McCulloch	Oxford	Oxfordshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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