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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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London, Reino Unido, SE1 7EH
- St Thomas' Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Caso cruzado
- Perspectivas temporales: Futuro
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Oxygen concentration while wearing purpose-designed mask
Periodo de tiempo: 40 minutes starting from intervention (donning of mask)
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5-minute measurement of oxygen concentration in inspired and expired gases
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40 minutes starting from intervention (donning of mask)
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Oxygen concentration while wearing improvised snorkel-based mask
Periodo de tiempo: 40 minutes starting from intervention (donning of mask)
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5-minute measurement of oxygen concentration in inspired and expired gases
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40 minutes starting from intervention (donning of mask)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Carbon dioxide concentration while wearing purpose-designed mask
Periodo de tiempo: 40 minutes starting from intervention (donning of mask)
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5 minute measurement of carbon dioxide concentration in inspired and expired gases
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40 minutes starting from intervention (donning of mask)
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Carbon dioxide concentration while wearing improvised snorkel-based mask
Periodo de tiempo: 40 minutes starting from intervention (donning of mask)
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5 minute measurement of carbon dioxide concentration in inspired and expired gases
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40 minutes starting from intervention (donning of mask)
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Heart rate while wearing purpose-designed mask
Periodo de tiempo: 40 minutes starting from intervention (donning of mask)
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5 minute measurement of heart rate
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40 minutes starting from intervention (donning of mask)
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Heart rate while wearing improvised snorkel-based mask
Periodo de tiempo: 40 minutes starting from intervention (donning of mask)
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5 minute measurement of heart rate
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40 minutes starting from intervention (donning of mask)
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Respiratory rate while wearing purpose-designed mask
Periodo de tiempo: 40 minutes starting from intervention (donning of mask)
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5 minute measurement of respiratory rate
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40 minutes starting from intervention (donning of mask)
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Respiratory rate while wearing improvised snorkel-based mask
Periodo de tiempo: 40 minutes starting from intervention (donning of mask)
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5 minute measurement of respiratory rate
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40 minutes starting from intervention (donning of mask)
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Oxygen saturation while wearing purpose-designed mask
Periodo de tiempo: 40 minutes starting from intervention (donning of mask)
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5 minute measurement of oxygen saturation
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40 minutes starting from intervention (donning of mask)
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Oxygen saturation while wearing improvised snorkel-based mask
Periodo de tiempo: 40 minutes starting from intervention (donning of mask)
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5 minute measurement of oxygen saturation
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40 minutes starting from intervention (donning of mask)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Paul R Greig, MBChB, Guy's and St Thomas' NHS Foundation Trust
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- TAP_PRG_21_04_2020_2
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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