HealthySTRIPE-3NCT04362163
Study for Testing and Reviewing Improvised PPE Effectiveness 3 (STRIPE-3)
An observational study of Healthy, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthy
- What is being tested?
- Snorkel-based improvised personal protective equipment
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2020to 5 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Healthy
- Being tested
- Snorkel-based improvised personal protective equipment
- Keywords
- Personal protective equipment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Snorkel-based improvised personal protective equipmentDevice
An improvised PPE design based on a full face snorkel mask mated to a heat-and-moisture exchange filter via a 3D printed adaptor.
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen concentration while wearing purpose-designed mask
5-minute measurement of oxygen concentration in inspired and expired gases
Measured: 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
Measured: 40 minutes starting from intervention (donning of mask)
Secondary outcomes (8)
Carbon dioxide concentration while wearing purpose-designed mask
5 minute measurement of carbon dioxide concentration in inspired and expired gases
Measured: 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
Measured: 40 minutes starting from intervention (donning of mask)
Heart rate while wearing purpose-designed mask
5 minute measurement of heart rate
Measured: 40 minutes starting from intervention (donning of mask)
Heart rate while wearing improvised snorkel-based mask
5 minute measurement of heart rate
Measured: 40 minutes starting from intervention (donning of mask)
Respiratory rate while wearing purpose-designed mask
5 minute measurement of respiratory rate
Measured: 40 minutes starting from intervention (donning of mask)
Respiratory rate while wearing improvised snorkel-based mask
5 minute measurement of respiratory rate
Measured: 40 minutes starting from intervention (donning of mask)
Oxygen saturation while wearing purpose-designed mask
5 minute measurement of oxygen saturation
Measured: 40 minutes starting from intervention (donning of mask)
Oxygen saturation while wearing improvised snorkel-based mask
5 minute measurement of oxygen saturation
Measured: 40 minutes starting from intervention (donning of mask)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 May 2020
- Primary completion5 Jun 2020
- Study completion5 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul R Greig, MBChB, Study chair, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362163
- Sponsor's protocol ID
- TAP_PRG_21_04_2020_2
- Acronym
- STRIPE-3
- Status last verified
- Apr 2020
- First submitted
- 21 Apr 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for Testing and Reviewing Improvised PPE Effectiveness 3 (STRIPE-3) - a Third Comparative Trial Assessing the Safety of Improvised PPE
- ClinicalTrials.gov ID
- NCT04362163
- Acronym / sponsor ID
- STRIPE-3 / TAP_PRG_21_04_2020_2
- Conditions
- Healthy
- Keywords
- Personal protective equipment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 5 Jun 2020 (actual)
- Study completion
- 5 Jun 2020 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Snorkel-based improvised personal protective equipmentAn improvised PPE design based on a full face snorkel mask mated to a heat-and-moisture exchange filter via a 3D printed adaptor. | Device | – |
Primary outcome
Oxygen concentration while wearing purpose-designed mask
Time frame: 40 minutes starting from intervention (donning of mask)
5-minute measurement of oxygen concentration in inspired and expired gases
Oxygen concentration while wearing improvised snorkel-based mask
Time frame: 40 minutes starting from intervention (donning of mask)
5-minute measurement of oxygen concentration in inspired and expired gases
8 secondary outcomes
Carbon dioxide concentration while wearing purpose-designed mask
Time frame: 40 minutes starting from intervention (donning of mask)
Carbon dioxide concentration while wearing improvised snorkel-based mask
Time frame: 40 minutes starting from intervention (donning of mask)
Heart rate while wearing purpose-designed mask
Time frame: 40 minutes starting from intervention (donning of mask)
Heart rate while wearing improvised snorkel-based mask
Time frame: 40 minutes starting from intervention (donning of mask)
Respiratory rate while wearing purpose-designed mask
Time frame: 40 minutes starting from intervention (donning of mask)
Respiratory rate while wearing improvised snorkel-based mask
Time frame: 40 minutes starting from intervention (donning of mask)
Oxygen saturation while wearing purpose-designed mask
Time frame: 40 minutes starting from intervention (donning of mask)
Oxygen saturation while wearing improvised snorkel-based mask
Time frame: 40 minutes starting from intervention (donning of mask)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul R Greig, MBChB study chair
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen concentration while wearing purpose-designed mask (time frame: 40 minutes starting from intervention (donning of mask)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.