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Validation of a Connected Patch, an Alternative to Conventional Monitoring

3 de fevereiro de 2020 atualizado por: Hopital Foch
The hypothesis is that this connected patch could be used in surgical departments to detect early a cardiovascular or respiratory complication and therefore to treat it without delay. However, it has not been validated in a hospital setting; that is the purpose of this project. This step of validating the connected monitoring object is required in different places: post-interventional surveillance room that approaches a conventional hospital room, and operating room where artifacts are numerous. Validation will be done by comparing data from General Electric's conventional monitors, with data from patches.

Visão geral do estudo

Status

Retirado

Condições

Intervenção / Tratamento

Descrição detalhada

When patients operated on outside intensive care or intensive care units are hospitalized, vital signs are collected intermittently by various conventional devices. During the follow-up period of these patients, it is possible that abnormal vital signs that may identify clinical deterioration may appear a few minutes to a few hours before a serious adverse event (infection etc.) occurs. These signals often go unnoticed due to infrequent monitoring.

The establishment of teams to ensure a rapid response would improve the safety of hospitalized patients for whom the detection of abnormal vital signs predictive of clinical deterioration would generate an alarm. This system is based on the identification of patients at risk and the rapid intervention of the team.

One of the crucial issues is therefore the speed of the alarm and its reliability.

The evolution of electronic technology offers the possibility of using inexpensive portable devices (connected patches) that can provide information on vital signs in real time. Vital signs collected by these devices could be analyzed to predict clinical deterioration prior to hospital staff visits, especially at night and on weekends when staffing levels are generally lower.

The connected patch used in this research is the Scaléo Médical company's device "myAngel VitalSigns". The long-term objective would be to be able to use this connected patch in surgical departments to detect early a complication, particularly of a cardiovascular or respiratory nature, and therefore to treat it without wasting time. However, it has not been validated in a hospital setting; that is the purpose of the project.

The objective of this research is therefore to validate Scaléo Médical's connected patch in different locations: post-interventional surveillance room that approaches a conventional hospital room, operating room where artifacts are numerous.

Tipo de estudo

Intervencional

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Suresnes, França, 92150
        • Hôpital Foch

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 85 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • patient over 18 and under 85 years of age
  • patient requiring general anesthesia for extra-thoracic surgery
  • the patient's position during the operation is in supine position only
  • patient affiliated to or benefiting from social security, excluding State Medical Assistance
  • patient with written consent

Exclusion Criteria:

  • pregnant or breastfeeding patients
  • patients known to have severe skin reactions to adhésives
  • patient whose surgical procedure prevents the patch from being placed (intervention on the thorax)
  • patients deprived of their liberty or under guardianship

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Validação de patch conectado
Uso de patch conectado para coletar pressão arterial, frequência cardíaca, frequência respiratória, saturação arterial de oxigênio e temperatura

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Concordance of blood pressure value measured by 2 different devices after surgery
Prazo: 36 hours maximum after the surgery
Comparison between blood pressure measured by conventional medical monitoring device and by connected patch
36 hours maximum after the surgery
Concordance of heart rate value measured by 2 different devices after surgery
Prazo: 36 hours maximum after the surgery
Comparison between heart rate measured by conventional medical monitoring device and by connected patch
36 hours maximum after the surgery
Concordance of respiratory rate value measured by 2 different devices after surgery
Prazo: 36 hours maximum after the surgery
Comparison between respiratory rate measured by conventional medical monitoring device and by connected patch
36 hours maximum after the surgery
Concordance of arterial oxygen saturation value measured by 2 different devices after surgery
Prazo: 36 hours maximum after the surgery
Comparison between arterial oxygen saturation measured by conventional medical monitoring device and by connected patch
36 hours maximum after the surgery
Concordance of temperature value measured by 2 different devices after surgery
Prazo: 36 hours maximum after the surgery
Comparison between temperature measured by conventional medical monitoring device and by connected patch
36 hours maximum after the surgery

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Concordance of blood pressure value measured by 2 different devices during surgery
Prazo: During surgery
Comparison between blood pressure measured by conventional medical monitoring device and by connected patch
During surgery
Concordance of heart rate value measured by 2 different devices during surgery
Prazo: During surgery
Comparison between heart rate measured by conventional medical monitoring device and by connected patch
During surgery
Concordance of respiratory rate value measured by 2 different devices during surgery
Prazo: During surgery
Comparison between respiratory rate measured by conventional medical monitoring device and by connected patch
During surgery
Concordance of arterial oxygen saturation value measured by 2 different devices during surgery
Prazo: During surgery
Comparison between arterial oxygen saturation measured by conventional medical monitoring device and by connected patch
During surgery
Concordance of temperature value measured by 2 different devices during surgery
Prazo: During surgery
Comparison between temperature value measured by conventional medical monitoring device and by connected patch
During surgery
Blood pressure artifact
Prazo: From surgery to 36 hours maximum after the surgery
Value of blood pressure will be considered as artifact if systolic blood pressure value < 80 or > 200 and diastolic blood pressure > 110
From surgery to 36 hours maximum after the surgery
Heart rate artifact
Prazo: From surgery to 36 hours maximum after the surgery
Value of heart rate will be considered as artifact if value < 40 or > 140
From surgery to 36 hours maximum after the surgery
Respiratory rate artifact
Prazo: From surgery to 36 hours maximum after the surgery
Value of respiratory rate will be considered as artifact if value < 8 or > 36
From surgery to 36 hours maximum after the surgery
Arterial oxygen saturation artifact
Prazo: From surgery to 36 hours maximum after the surgery
Value of arterial oxygen saturation will be considered as artifact if value < 85 %
From surgery to 36 hours maximum after the surgery
Acceptability of connected patch: numerical scale
Prazo: During the surgery and through study completion
Evaluation of connected patch with a simple numerical scale between 0 and 10: 0 representing a very poor tolerance of the device and leading to premature interruption of the collection and 10 a perfect tolerance allowing the patch to be maintained for several consecutive days
During the surgery and through study completion

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Morgan Le Guen, Hôpital Foch

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Antecipado)

1 de janeiro de 2020

Conclusão Primária (Antecipado)

4 de setembro de 2020

Conclusão do estudo (Antecipado)

4 de setembro de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

6 de agosto de 2019

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de agosto de 2019

Primeira postagem (Real)

12 de agosto de 2019

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de fevereiro de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de fevereiro de 2020

Última verificação

1 de agosto de 2019

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 2017055F

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Não

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

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 .

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