Noninvasive Positive Pressure Ventilation for Early Extubation of Acute Hypoxemic Respiratory Failure (NPPV)
Acute hypoxaemic respiratory failure (AHRF) refers to pathological states in which arterial blood oxygenation is severely impaired，and which need invasive positive pressure ventilation (IPPV) as respiratory support technique in most cases.However，IPPV carries well-known risks of complications such as ventilator induced lung injury (VILI) or ventilator associated pneumonia (VAP)，and the incidence of which is increased as the prolongation of IPPV so as to lead to higher mortality rate. Consequently，early extubation is extraordinarily necessary.
More recently, NPPV has shown to shorten the duration of IPPV，reduce the mortality and morbidity rates in patients with chronic obstructive pulmonary disease (COPD). Despite this evidence, the efficacy of NPPV in patients with AHRF has not been evidenced. However，NPPV has been shown to provide adequate ventilation and oxygenation，and reduce inspiratory muscle effort，neuromuscular drive，and dyspnea scores. Moreover，to some patints，NPPV is similar with IPPV in providing oxygenation.
The duration of weaning is from the first day a patient met standard criteria for weaning readiness to the time of successful extubation (lasting at least 48 h)，which represents 40-50% of the total duration of IPPV.As a result，duration of IPPV would be shortened if that of weaning was shortened.
The investigators hypothesized that in mechanical ventilated patients with AHRF who met standard criteria for weaning readiness and suffer failure of spontaneous breathing trial, use of NPPV for early extubation, providing adequate ventilation and oxygenation, would shorten the duration of IPPV as the primary end-point variable, thereby reduce the incidence of complication and mortality rates. Accordingly, the investigators conducted a prospective，randomized clinical trial to assess the efficacy of this strategy compared with the conventional-weaning approach.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Beijing
-
Beijing, Beijing, China, 100020
- Beijing Chao Yang Hospital
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Orotracheal intubation
- Arterial oxygen tension (PaO2)<60mmHg（venturi mask，FiO2=0.5），and arterial carbon dioxide tension(PaCO2)≤45mmHg；
- Meeting standard criteria for weaning readiness
- Suffering failure of spontaneous breathing trial.
Exclusion Criteria:
- Age<18
- Duration of invasive positive pressure ventilation<48h
- Tracheotomy
- Percentage of cuff leak volume in tidal volume<15.5%
- Unable to spontaneously clear secretions from their airway
- Recent oral，nasal，facial or cranial trauma or surgery
- Recent gastric or esophageal surgery
- Active upper gastro-intestinal bleeding
- Severe abdominal distension
- Lack of co-operation
- Chronic respiratory disease such as chronic obstructive pulmonary disease，asthma，interstitial lung disease,etc.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: noninvasive positive pressure ventilation
|
Patients in whom the spontaneous breathing trial fail and in whom exclusion criteria are not present during this period were randomly allocated.
Patients who are randomized to NPPV goup will be extubated and non-invasive ventilation (BiPAP Vision, Respironics Inc., Murrysville，Pennsylvania) will be delivered immediately after extubation using spontaneous/timed (S/T) mode.
Expiratory positive airways pressure (PEEP) was initially set at 4 cmH2O and gradually increased to 6-8 cmH2O or more；and fraction of inspired oxygen (FiO2) was set to achieve pulse oximeter oxygen saturation (SpO2) >92% in cooperation with PEEP.
On condition that tidal volume is no less than 6ml/kg，continuous positive airway pressure (CPAP) is permitted to apply，in which the adjusting procedures of CPAP and FiO2 is similar with PEEP and FiO2 in S/T mode.
NPPV is terminated When patients can spontaneously breath oxygen provided by a Venturi device at FiO2≤0.35 for more than 24 hours with SpO2>92%.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Duration of invasive positive pressure ventilation
Prazo: two year
|
two year
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Incidence of ventilator associated pneumonia
Prazo: two year
|
two year
|
|
Intensive care unit mortality
Prazo: two years
|
two years
|
|
Hospital mortality
Prazo: two years
|
two years
|
|
90-day survival after entry
Prazo: two years
|
two years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Wang Chen, MD, Beijing Chao Yang Hospital
- Diretor de estudo: Zhan Q Yuan, MD, Beijing Chao Yang Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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 (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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- BeijingCYH-ICU-000
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 .