Autotitrating Versus Standard Non-invasive Ventilation (NIV) in Acute Exacerbation of Respiratory Failure
Autotitrating Non-invasive Ventilation (NIV) Versus Standard NIV; a Randomised Crossover Trial in Patients With Acute Exacerbation of Chronic Respiratory Failure
The aim of the study is to compare the efficacy and tolerance of autotitrating non-invasive ventilation (NIV) versus standard NIV in patients admitted to hospital with acute exacerbation of chronic respiratory failure.
The investigators hypothesise that autotitrating NIV will ventilate patients with acute exacerbations of chronic respiratory failure as effectively as standard NIV.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The aim of the study is to compare the effect of two types of noninvasive ventilator (a small machine that assists breathing) in patients admitted to hospital with a sudden worsening of their existing breathing insufficiency, including an increase of carbon dioxide in the blood (hypercapnia) and acidity of the blood. Noninvasive ventilation (NIV) is standard therapy for patients with acute hypercapnic exacerbations (sudden worsening of existing breathing insufficiency) of both chronic obstructive pulmonary disease (COPD) and nonCOPD patients.
The most common type of NIV is bilevel pressure support which assists patient breathing by delivering different levels of air pressure during inspiration and expiration via a mask covering the nose or nose and mouth. Standard bilevel NIV (VPAP™) has been further developed to create a new automatically adjusting NIV (AutoVPAP™). Automatically adjusting NIV varies the inspiratory air pressure according to the airflow rates generated by the patient. This may improve patient comfort, hours of NIV use and recovery time.
Patients over the age of 18 admitted to Royal Brompton Hospital respiratory ward will be considered for entry into this randomised crossover study. If eligible for inclusion and willing to take part patients will be setup on automatically adjusting NIV or standard NIV, assigned in random order. After 24 hours on the first NIV the patient will be swapped to the alternative NIV for a further 24 hours of treatment.
Tipo de estudo
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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London, Reino Unido, SW3 6NP
- Royal Brompton 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:
- patients admitted or transferred to Royal Brompton Hospital with acute exacerbation of chronic respiratory failure, or inpatients who suffer a deterioration in respiratory status, defined as 7.25 < pH < 7.35, PaCO2 > 6.0kPa, and respiratory rate > 20bpm
Exclusion Criteria:
- < 18 years old
- pH < 7.25
- need for immediate intubation
- uncontrolled cardiac failure
- hypotensive (systolic blood pressure < 90mmHg)
- acute myocardial infarction
- acute dysrhythmia
- other system failure (e.g. acute renal failure, liver failure)
- moderate or severe bulbar weakness
- inability to understand rationale and/or consent form for study
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: autotitrating NIV
approximately 24 hours using autotitrating non-invasive ventilation for as many hours as possible whilst an inpatient in hospital
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Automatically titrated non-invasive ventilator, with target gross alveolar ventilation, end expiratory positive pressure, and back up respiratory rate determined by the clinician based on height and weight.
The NIV must be used for as many hours as possible over the 24 hour period but breaks for meals, physiotherapy and bathroom are allowed.
Outros nomes:
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Comparador Ativo: Standard non-invasive ventilation
approximately 24 hours using standard non-invasive ventilation for as many hours as possible whilst an inpatient in hospital.
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Standard non-invasive ventilator, with inspiratory and expiratory positive pressure determined by the healthcare professional.
The NIV must be used for as many hours as possible over the 24 hour period but breaks for meals, physiotherapy and bathroom are allowed.
Outros nomes:
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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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pH at 1+ hour
Prazo: 1 hour
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pH of arterial blood after 1 hour of treatment with non-invasive ventialtion compared baseline value
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1 hour
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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pH at 4+ hours
Prazo: 4+ hours of NIV treatment
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pH of arterial blood after 4 hours of treatment with non-invasive ventialtion compared to baseline value
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4+ hours of NIV treatment
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Respiratory Rate at 1+ hour
Prazo: 1+ hour of NIV treatment
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Respiratory rate after 1 hour of treatment with non-invasive ventilation compared to baseline value
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1+ hour of NIV treatment
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Respiratory rate at 4+ hours
Prazo: 4+ hours of NIV treatment
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Respiratory rate after 4 hours of treatment with non-invasive ventilation compared to baseline value
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4+ hours of NIV treatment
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overnight mean transcutaneous carbon dioxide
Prazo: 24 hours
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mean overnight transcutaneous carbon dioxide during sleep period
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24 hours
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PaCO2 at 1+ hours
Prazo: 1+ hours of NIV treatment
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Carbon dixoide level of arterial blood after 1 hour of treatment with non-invasive ventilation compared to baseline
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1+ hours of NIV treatment
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PaCO2 at 4+ hours
Prazo: 4+ hours of NIV treatment
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Carbon dioxide level in arterial blood after 4 hours of treatment with non-invasive ventilation compared to baseline value
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4+ hours of NIV treatment
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PaO2 at 1+ hour
Prazo: 1+ hour of NIV treatment
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Oxygen level in arterial blood after 1 hour of treatment with non-invasive ventilation compared to baseline value
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1+ hour of NIV treatment
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PaO2 at 4+ hours
Prazo: 4+ hours of NIV treatment
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Oxygen level in arterial blood after 4+ hours of treatment with non-invasive ventilation compared to baseline value
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4+ hours of NIV treatment
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Colaboradores e Investigadores
Patrocinador
Colaboradores
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 (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
- Doenças do Sistema Nervoso
- Doenças Respiratórias
- Apnéia
- Distúrbios Respiratórios
- Distúrbios do Sono Intrínsecos
- Dissônias
- Distúrbios do Sono Vigília
- Doenças pulmonares
- Supernutrição
- Distúrbios Nutricionais
- Sinais e Sintomas Respiratórios
- Síndromes da Apneia do Sono
- Obesidade
- Apnéia do Sono, Obstrutiva
- Doenças Pulmonares Obstrutivas
- Doença Pulmonar Obstrutiva Crônica
- Insuficiência Respiratória
- Hipoventilação
- Síndrome de Hipoventilação Obesidade
- Doenças Neuromusculares
Outros números de identificação do estudo
- 10/H0808/56
- R&D No. 2010LF008B (Outro identificador: Research & Development Department, RBH)
- CI/2010/0027 (Outro identificador: Medicines & Healthcare Products Regularoty Agency (devices))
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