Ignite Creation Date:
2024-05-06 @ 2:34 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04362163
Status:
COMPLETED
Last Update Posted:
2020-06-09
First Post:
2020-04-21
Brief Title:
Study for Testing and Reviewing Improvised PPE Effectiveness 3 STRIPE-3
Sponsor:
Guys and St Thomas NHS Foundation Trust
Organization:
Guys and St Thomas NHS Foundation Trust
Study Overview
Official Title:
Study for Testing and Reviewing Improvised PPE Effectiveness 3 STRIPE-3 - a Third Comparative Trial Assessing the Safety of Improvised PPE
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STRIPE-3
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None