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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.

Studieoversikt

Status

Fullført

Forhold

Studietype

Observasjonsmessig

Registrering (Faktiske)

10

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • London, Storbritannia, SE1 7EH
        • St Thomas' Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

N/A

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Case-Crossover
  • Tidsperspektiver: Potensielle

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Oxygen concentration while wearing purpose-designed mask
Tidsramme: 40 minutes starting from intervention (donning of 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
Tidsramme: 40 minutes starting from intervention (donning of mask)
5-minute measurement of oxygen concentration in inspired and expired gases
40 minutes starting from intervention (donning of mask)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Carbon dioxide concentration while wearing purpose-designed mask
Tidsramme: 40 minutes starting from intervention (donning of 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
Tidsramme: 40 minutes starting from intervention (donning of 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
Tidsramme: 40 minutes starting from intervention (donning of mask)
5 minute measurement of heart rate
40 minutes starting from intervention (donning of mask)
Heart rate while wearing improvised snorkel-based mask
Tidsramme: 40 minutes starting from intervention (donning of mask)
5 minute measurement of heart rate
40 minutes starting from intervention (donning of mask)
Respiratory rate while wearing purpose-designed mask
Tidsramme: 40 minutes starting from intervention (donning of mask)
5 minute measurement of respiratory rate
40 minutes starting from intervention (donning of mask)
Respiratory rate while wearing improvised snorkel-based mask
Tidsramme: 40 minutes starting from intervention (donning of mask)
5 minute measurement of respiratory rate
40 minutes starting from intervention (donning of mask)
Oxygen saturation while wearing purpose-designed mask
Tidsramme: 40 minutes starting from intervention (donning of mask)
5 minute measurement of oxygen saturation
40 minutes starting from intervention (donning of mask)
Oxygen saturation while wearing improvised snorkel-based mask
Tidsramme: 40 minutes starting from intervention (donning of mask)
5 minute measurement of oxygen saturation
40 minutes starting from intervention (donning of mask)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studiestol: Paul R Greig, MBChB, Guy's and St Thomas' NHS Foundation Trust

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mai 2020

Primær fullføring (Faktiske)

5. juni 2020

Studiet fullført (Faktiske)

5. juni 2020

Datoer for studieregistrering

Først innsendt

21. april 2020

Først innsendt som oppfylte QC-kriteriene

23. april 2020

Først lagt ut (Faktiske)

24. april 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. juni 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. juni 2020

Sist bekreftet

1. april 2020

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • TAP_PRG_21_04_2020_2

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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