Clinical trial NCT04362163: Study for Testing and Reviewing Improvised PPE Effectiveness 3 (STRIPE-3)
Official title: Study for Testing and Reviewing Improvised PPE Effectiveness 3 (STRIPE-3) - a Third Comparative Trial Assessing the Safety of Improvised PPE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Personal protective equipment
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Oxygen concentration while wearing purpose-designed mask
timeFrame: 40 minutes starting from intervention (donning of mask)
measure: Oxygen concentration while wearing improvised snorkel-based mask
timeFrame: 40 minutes starting from intervention (donning of mask)
Secondary outcomes:
measure: Carbon dioxide concentration while wearing purpose-designed mask
timeFrame: 40 minutes starting from intervention (donning of mask)
measure: Carbon dioxide concentration while wearing improvised snorkel-based mask
timeFrame: 40 minutes starting from intervention (donning of mask)
measure: Heart rate while wearing purpose-designed mask
timeFrame: 40 minutes starting from intervention (donning of mask)
measure: Heart rate while wearing improvised snorkel-based mask
timeFrame: 40 minutes starting from intervention (donning of mask)
measure: Respiratory rate while wearing purpose-designed mask
timeFrame: 40 minutes starting from intervention (donning of mask)
measure: Respiratory rate while wearing improvised snorkel-based mask
timeFrame: 40 minutes starting from intervention (donning of mask)
measure: Oxygen saturation while wearing purpose-designed mask
timeFrame: 40 minutes starting from intervention (donning of mask)
measure: Oxygen saturation while wearing improvised snorkel-based mask
timeFrame: 40 minutes starting from intervention (donning of mask)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Thomas' Hospital
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Paul R Greig, MBChB
role: STUDY_CHAIR
References: