Study for Testing and Reviewing Improvised PPE Effectiveness 3 (STRIPE-3) (STRIPE-3)

Study for Testing and Reviewing Improvised PPE Effectiveness 3 (STRIPE-3) - a Third Comparative Trial Assessing the Safety of Improvised PPE

Personal protective equipment (PPE) is vital to ensuring staff safety during the COVID-19 pandemic. Properly designed, formal PPE (fPPE) is in increasingly short supply, and a series of improvised PPE (iPPE) designs have been widely circulated on the internet, particularly on social media. Groups have started to publicise these devices through websites and the lay press. Some are even using crowd-funding to finance the purchase of these systems with the intention of supplying NHS workers in place of approved systems.

It is not clear what degree of testing these systems have undergone. The investigators are already planning trials formally investigating the quality of seal offered by these improvised systems. Currently the team are investigating a designed based on a modified snorkel mask (STRIPE-1). In the current study the investigators wish to extend this investigation to consider the atmosphere within the mask.

This is an important question, as modifications to the snorkel design have changed the way gases mix within the system. This might increase the risk that the user will rebreathe expired gases, which will dilute the amount of oxygen available to them, and increase the carbon dioxide levels to which they are exposed. At extreme deviations, these might pose a potential health hazard over and above the risks posed by COVID-19 exposure via a poor mask seal.

This study will therefore recruit a convenience sample of 10, and request they wear two masks sequentially. These masks will comprise: a formally designed and tested commercial FFP3 mask, and one design of improvised PPE, based on the snorkel design available on the internet.

Each mask will be worn for a total of 40 minutes. In the first 20 minutes measurements will be taken with the user at rest. In the second 20 minutes measurements will be taken while the user undertakes light exercise.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Snorkel-based improvised personal protective equipment

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 7EH
    • St Thomas' Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Recruits will be drawn from amongst staff at Guy's and St Thomas' NHS Foundation Trust (London, UK) who are required to be fit-tested on tight-fitting FFP3 masks as part of their normal clinical duties.

Description

Inclusion Criteria:

• Willing and able to give informed consent for participation in the study
• Healthy adults, male or female, aged 18 or more
• Clean-shaven at the point of testing
• Willing and able to undertake 20 minutes of light exercise e.g. stepping

Exclusion Criteria:

• They have facial hair that would disrupt the seals of the mask
• They have significant facial injuries or malformations that preclude a good mask seal

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen concentration while wearing purpose-designed mask	5-minute measurement of oxygen concentration in inspired and expired gases	40 minutes starting from intervention (donning of mask)
Oxygen concentration while wearing improvised snorkel-based mask	5-minute measurement of oxygen concentration in inspired and expired gases	40 minutes starting from intervention (donning of mask)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Carbon dioxide concentration while wearing purpose-designed mask	5 minute measurement of carbon dioxide concentration in inspired and expired gases	40 minutes starting from intervention (donning of mask)
Carbon dioxide concentration while wearing improvised snorkel-based mask	5 minute measurement of carbon dioxide concentration in inspired and expired gases	40 minutes starting from intervention (donning of mask)
Heart rate while wearing purpose-designed mask	5 minute measurement of heart rate	40 minutes starting from intervention (donning of mask)
Heart rate while wearing improvised snorkel-based mask	5 minute measurement of heart rate	40 minutes starting from intervention (donning of mask)
Respiratory rate while wearing purpose-designed mask	5 minute measurement of respiratory rate	40 minutes starting from intervention (donning of mask)
Respiratory rate while wearing improvised snorkel-based mask	5 minute measurement of respiratory rate	40 minutes starting from intervention (donning of mask)
Oxygen saturation while wearing purpose-designed mask	5 minute measurement of oxygen saturation	40 minutes starting from intervention (donning of mask)
Oxygen saturation while wearing improvised snorkel-based mask	5 minute measurement of oxygen saturation	40 minutes starting from intervention (donning of mask)

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Investigators: Study Chair: Paul R Greig, MBChB, Guy's and St Thomas' NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): June 5, 2020
• Study Completion (Actual): June 5, 2020

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: April 23, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 4, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Personal protective equipment
• Other Study ID Numbers: TAP_PRG_21_04_2020_2

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