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- Ensaio Clínico NCT04813250
Ventilatory Strategies After Cardiopulmonary Bypass Evaluated by Electrical Impedance Tomography
The Effects of Ventilatory Strategies on Pulmonary Function After Cardiopulmonary Bypass Evaluated by Electrical Impedance Tomography in Patients Undergoing Cardiac Surgery
Pulmonary complications after cardiac surgeries are common. It is one of the most crucial concerns of cardiac surgeons and anesthesiologists. These adverse events may vary from a mild respiratory dysfunction to acute respiratory distress syndrome (ARDS). One of the most public reasons of these complications is atelectasis that would result in hypoxia and pneumonia. Any of these adverse events rises the prevalence of morbidity and mortality. The chief inducing causes for atelectasis are CPB and dropped blood perfusion and ventilation of the lungs. The ventilation arrest is related with a high frequency of retained bronchial sections, local atelectasis, decrease in arterial O2 concentrations as a effect of surge in arteriovenous shunt, declined lung compliance, pulmonary edema and hence increased risk of nosocomial infections.
Electrical Impedance Tomography (EIT) is a non-invasive, radiation-free, real time bedside imaging modality, which provide the assessment of regional gas volume and lung ventilation. EIT has been experienced in quite a lot of animal and clinical applications including optimization of mechanical ventilator strategies and recognition of respiratory adverse events. Besides, EIT has been used to recognize ideal PEEP by detection of homogenous ventilation in non-dependent and dependent lung regions. Homogeneous ventilation is key for inhibition of ventilator-induced lung injury.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Neihu Dist
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Taipei City, Neihu Dist, Taiwan, 11490
- Department of Anesthesiology, Tri-Service General Hospital
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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:
- Age between 20-80 year-old
- Adult patients receiving elective cardiac surgery with hypothermic CPB
Exclusion Criteria:
- Patients were excluded if they had complicating comorbidities, such as chronic hepatic or renal insufficiency, acute cardiopulmonary failure requiring mechanical ventilation, intra-aortic balloon pump, or extracorporeal membrane oxygenation
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Falso: Group R
IMV(intermittent mandatory ventilation) Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight)
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Ventilation strategies with 4 kinds of ventilator mode since weaning cardiopulmonary bypass (CPB), Four group were control EtCO2 between 35~45mmHg by adjusting respiratory rate, EIT Measurements were performed under supine position
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Experimental: Group RP
Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) + PEEP : 6 cm H2O
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Ventilation strategies with 4 kinds of ventilator mode since weaning cardiopulmonary bypass (CPB), Four group were control EtCO2 between 35~45mmHg by adjusting respiratory rate, EIT Measurements were performed under supine position
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Experimental: Group RI
Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) + Reverse IE ratio ventilation( I:E=1:1)
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Ventilation strategies with 4 kinds of ventilator mode since weaning cardiopulmonary bypass (CPB), Four group were control EtCO2 between 35~45mmHg by adjusting respiratory rate, EIT Measurements were performed under supine position
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Experimental: Group RPI
Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) + PEEP : 6 cm H2O + Reverse IE ratio ventilation( I:E=1:1)
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Ventilation strategies with 4 kinds of ventilator mode since weaning cardiopulmonary bypass (CPB), Four group were control EtCO2 between 35~45mmHg by adjusting respiratory rate, EIT Measurements were performed under supine position
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The correlation between Different ventilation mode and the relevant value of EIT
Prazo: since weaning cardiopulmonary bypass (CPB) to the end of surgery
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Compare the correlation between Different ventilation mode and the relevant value of EIT in the population of open heart surgery patient
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since weaning cardiopulmonary bypass (CPB) to the end of surgery
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The demographic characteristics and relevant value of EIT
Prazo: since weaning cardiopulmonary bypass (CPB) to the end of surgery
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Campare the demographic characteristics and relevant value of EIT in the population of open heart surgery patient
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since weaning cardiopulmonary bypass (CPB) to the end of surgery
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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If the different ventilation mode setting can improve clinical outcome
Prazo: since weaning cardiopulmonary bypass (CPB) to the end of surgery
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Identify the different ventilation mode setting in open heart surgery patient if can improve clinical care benifit.
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since weaning cardiopulmonary bypass (CPB) to the end of surgery
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The correlation between heart function & oxygenation and different ventilation mode
Prazo: since weaning cardiopulmonary bypass (CPB) to the end of surgery
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Survey the correlation between heart function & oxygenation and different ventilation mode
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since weaning cardiopulmonary bypass (CPB) to the end of surgery
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
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
Outros números de identificação do estudo
- Ventilatory with EIT post CPB
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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