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- Ensaio Clínico NCT04053179
Validation of a Connected Patch, an Alternative to Conventional Monitoring
Visão geral do estudo
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
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
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Suresnes, França, 92150
- Hôpital Foch
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
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
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
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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
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Value of blood pressure will be considered as artifact if systolic blood pressure value < 80 or > 200 and diastolic blood pressure > 110
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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
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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
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From surgery to 36 hours maximum after the surgery
|
Arterial oxygen saturation artifact
Prazo: From surgery to 36 hours maximum after the surgery
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Value of arterial oxygen saturation will be considered as artifact if value < 85 %
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From surgery to 36 hours maximum after the surgery
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Acceptability of connected patch: numerical scale
Prazo: During the surgery and through study completion
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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
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During the surgery and through study completion
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Morgan Le Guen, Hôpital Foch
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Antecipado)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
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
Outros números de identificação do estudo
- 2017055F
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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