- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT04362163
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
-
London, Reino Unido, SE1 7EH
- St Thomas' Hospital
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Case-Crossover
- Perspectivas de Tempo: Prospectivo
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Oxygen concentration while wearing purpose-designed mask
Prazo: 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
Prazo: 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)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Carbon dioxide concentration while wearing purpose-designed mask
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 40 minutes starting from intervention (donning of mask)
|
5 minute measurement of oxygen saturation
|
40 minutes starting from intervention (donning of mask)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Paul R Greig, MBChB, Guy's and St Thomas' NHS Foundation Trust
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- TAP_PRG_21_04_2020_2
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .