Avaliação da frequência respiratória intrínseca durante a ventilação mecânica para acelerar a respiração espontânea e a extubação (INTRINSIC)
Avaliação da frequência respiratória intrínseca em pacientes adultos ventilados mecanicamente com disparo reverso como incentivo para acelerar a transição para respiração espontânea e extubação: ensaio clínico piloto randomizado - INTRÍNSICO
The goal of this study is to identify patients with reverse triggering who's the potential to breath spontaneously is hidden because of the ventilator management strategy by performing a simple 30sec-test with includes reducing the support from the ventilator. The findings will provide clear advice to doctors on how to better care for these patients.
This will be a pilot randomized clinical trial including 70 adult patients (aimed at equal number of men and woman) sedated and under controlled ventilation having reverse triggering. The study will be conducted in two ICUs: 1) St. Michael's Hospital, Toronto Canada and 2) Toronto Western Hospital, Toronto, Canada.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
The objective of this study is to investigate the impact of assessing intrinsic respiratory rate in mechanically ventilated patients with reverse triggering on the facilitation of transition to spontaneous breathing and successful extubation.
Patients will be excluded if under current use of continuous neuromuscular blocking agent or severe metabolic acidosis (Ph<7.25 at the time of study procedure.
Patients will be screened every morning from 8:00 am to 9:00 am all the patients under controlled ventilation to detect the presence of reverse triggering by looking at the screen on the ventilator (2-5 min observation). The research team (research MDs, physiotherapists and respiratory therapists) is very well trained at detecting reverse triggering. Patients will then be randomized to standard of care or intervention using a deferred consent model.
- Control group: standard care.
- Intervention group: The intervention is a simple brief test as follows: With the ventilator set with the patient clinical settings, it will be performed an up to 30sec-long or two inspiratory effort and expiratory occlusion maneuver on the ventilator and/or switch the patient to pressure support for up to 30sec-long to assess the presence of intrinsic respiratory rate.
If an intrinsic respiratory rate ≥8 breaths per minute is present and P/F ratio is ≥150 it will be performed a 5-minute "test" in pressure support ventilation with the pressure support level to match the clinical setting of the patient. If the patient tolerates well 5 minutes in pressure support (see criteria below) the clinical team will be informed:
- It will be indicated that the patient tolerated 5 min of pressure support ventilation and suggest to the clinicians and physician in charge to transition the patient to pressure support ventilation plus suggest reducing sedation.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Laurent Brochard, MD
- Número de telefone: 4168645686
- E-mail: laurent.brochard@unityhealth.to
Estude backup de contato
- Nome: Antenor Rodrigues, Ph.D.
- E-mail: antenor.rodrigues@unityhealth.to
Locais de estudo
-
-
Ontario
-
Toronto, Ontario, Canadá, M5B1W8
- Recrutamento
- St. Michael's Hospital
-
Contato:
- Nattapat Wongtirawit, M.D.
- Número de telefone: 6214 416-864-6060
- E-mail: nattapat.wongtirawit@unityhealth.to
-
Toronto, Ontario, Canadá
- Ainda não está recrutando
- Toronto Western Hospital
-
Contato:
- Irene Telias, MD, PhD
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Adult patients (aimed at equal number of men and woman) sedated and under controlled ventilation having reverse triggering.
Exclusion Criteria:
- under current use of continuous neuromuscular blocking agent or severe metabolic acidosis (Ph<7.25) at the time of study procedure.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: Standard Care
The participant will receive the current standard intensive care. |
|
|
Comparador Ativo: brief test
The intervention is a simple brief test as follows: With the ventilator set with the patient clinical settings, it will be performed an up to 30sec-long or two inspiratory effort and-expiratory occlusion maneuver on the ventilator and/or switch the patient to pressure support for up to 30sec-long to assess the presence of intrinsic respiratory rate. If an intrinsic respiratory rate ≥8 breaths per minute is present and P/F ratio is ≥150 it will be performed a 5-minute "test" in pressure support ventilation with the pressure support level to match the clinical setting of the patient. If the patient tolerates well 5 minutes in pressure support (see criteria below) the clinical team will be informed: - It will be indicated that the patient tolerated 5 min of PSV and suggest to the clinicians and physician in charge to transition the patient to pressure support ventilation plus suggest reducing sedation. |
The intervention is a simple brief test as follows: With the ventilator set with the patient clinical settings, it will be performed an up to 30sec-long or two inspiratory effort and-expiratory occlusion maneuver on the ventilator and/or switch the patient to pressure support for up to 30sec-long to assess the presence of intrinsic respiratory rate. If an intrinsic respiratory rate ≥8 breaths per minute is present and P/F ratio is ≥150 it will be performed a 5-minute "test" in pressure support ventilation with the pressure support level to match the clinical setting of the patient. If the patient tolerates well 5 minutes in pressure support (see criteria below) the clinical team will be informed: - It will be indicated that the patient tolerated 5 min of PSV and suggest to the clinicians and physician in charge to transition the patient to pressure support ventilation plus suggest reducing sedation. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of patients tolerating the transition to assisted breathing, or having an SBT, or being extubated within 48 hours
Prazo: 48 hours
|
Number of patients tolerating the transition to assisted breathing (e.g., Pressure Support Ventilation, Neurally Adjusted Ventilatory Assist, Proportional assist ventilation with load-adjustable gain factors), or having an SBT, or being extubated within 48 hours |
48 hours
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Laurent Brochard, Unity Health Toronto - St. Michael's Hospital
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 4902
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