Randomized Crossover of NAVA and Synchronized Intermittent Pressure Ventilation in Neonates and Infants
Respiratory Severity and Caloric Consumption on NAVA: Randomized Crossover Trial of NAVA and SIMV
This study is a single center, prospective cohort crossover study comparing mechanically ventilated neonates and infants on Neurally Adjusted Ventilatory Assist (NAVA) and synchronized intermittent mandatory ventilation with pressure control plus pressure support (SIMV(PC) + PS) modes.
This design will allow for direct comparison of two commonly used ventilator modalities in the neonatal intensive care unit (NICU) to determine if one mode is superior to the other with regards to respiratory mechanics and estimated energy expenditure.
It is hypothesized that neonates and infants will have improved respiratory severity score (MAP X FiO2) utilizing NAVA compared to the SIMV (PC) + PS mode but will have increased estimated energy expenditure.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
This single center, prospective cohort crossover study will involve mechanically ventilated neonates and infants who are determined to be on stable ventilator settings in either the NAVA or SIMV(PC) + PS modes. This design will allow for direct comparison of two commonly used ventilator modalities in the neonatal intensive care unit (NICU) to determine if one mode is superior to the other with regards to respiratory mechanics and energy expenditure.
Infants will be screened for stability criteria including: being stable on the ventilator in either SIMV (PC) + PS or NAVA mode, on weaning or unchanged ventilatory support in previous 12 hours, and no need of escalation of ventilatory pressure or rate in prior 12 hours.
After screening criteria is met and consent has been obtained, data will be retrospectively collected for 12 hours prior to randomization. After the subject is randomized, the infant will be stabilized and data will be collected for 12 hours in the randomized mode. Data will then be collected for 12 hours afterwards in the crossover mode. Data will be collected in areas of patient demographics, diagnoses, indications for mechanical ventilation, hemodynamic variables and respiratory parameters. While in each mode, the patient will also have indirect calorimetry obtained to determine estimated energy expenditure of each mode.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Missouri
-
Kansas City, Missouri, Estados Unidos, 64108
- Children's Mercy Hospital
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Neonates and infants, 22 weeks gestation age or older at birth
- Require mechanical ventilation for respiratory support in either SIMV (PC) + PS or NAVA modes
- Stable on the ventilator with a fractional inspired oxygen requirement (FiO2) of 0.60 or less.
- Stable on the ventilator with weaning or unchanged ventilatory support without need of escalation of ventilatory pressure or rate in prior 12 hours.
Exclusion Criteria:
- Major congenital anomalies
- Neurologic compromise of respiratory drive
- Phrenic nerve palsy
- Sedated enough to suppress respiratory drive
- Respiratory support with volume mechanical ventilation
- Respiratory support with high frequency oscillatory ventilation
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: Neurally Adjusted Ventilatory Assist
Subject will be randomized to NAVA ventilation.
Intervention is mechanical ventilation with Neurally Adjusted Ventilatory Assist for 12 hours.
|
The subject will be crossed over from the baseline ventilator mode to Neurally Adjusted Ventilatory Assist
The subject will be crossed over from the baseline ventilator mode to Synchronized Intermittent Mandatory Assist with Pressure Support
|
|
Outro: Synchronized Interm. Mandatory Assist
Subject will be randomized to SIMV(PC)PS ventilation.
Intervention is mechanical ventilation with Synchronized Intermittent Mandatory Assist with Pressure Support for 12 hours.
|
The subject will be crossed over from the baseline ventilator mode to Neurally Adjusted Ventilatory Assist
The subject will be crossed over from the baseline ventilator mode to Synchronized Intermittent Mandatory Assist with Pressure Support
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Respiratory Severity Score (MAP X FiO2)
Prazo: 12 hours and 24 hours
|
The respiratory severity score will be calculated throughout 24 hour time frame prior to and after study initiation to determine the subject's respiratory severity prior to the randomization, after randomization and after crossover.
The respiratory severity score (RSS) is a simplified severity score consisting of the mean airway pressure (MAP) multiplied by the fraction of inspired oxygen (FiO2).
This score ranges from 0 to 12, with a higher score indicating more severe disease.
|
12 hours and 24 hours
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Energy Expenditure
Prazo: 12 hours and 24 hours
|
The subject will have indirect calorimetry performed twice during the study on each mode, 12 hours after randomization and 12 hours after crossover to determine the approximate amount of energy expenditure needed for each mode of mechanical ventilation. Energy expenditure is calculated by using the Harris-Benedict equation, resulted in kcal/kg per day. |
12 hours and 24 hours
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jamie L Rosterman, DO, Children's Mercy Hospital Kansas City
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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 (Estimativa)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Crossover NAVA
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 .