High Flow Nasal Cannula Versus High Velocity Nasal Insufflation in Covid-19
High Flow Nasal Cannula Versus High Velocity Nasal Insufflation in Covid-19 Patients Admitted to Respiratory Intensive Care Unit of Assiut University Hospital
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
novel clinical syndrome caused by a previously unknown coronavirus, SARS-Cov-2, was first identified in Wuhan (China) in December 2019. Despite massive efforts to contain viral transmission, a worldwide epidemic has developed from this virus. This disease is presently known as COVID-19 COVID-19 pandemic reached over 45 million confirmed infections and claimed the lives of more than 1.2 million people worldwide. The clinical features of COVID-19 are diverse and range from asymptomatic to critical illness and death. Severe and critical cases represented 14% and 5% of laboratory-confirmed COVID-19 patients and need ICU admission Several non-invasive options exist to support COVID-19 patients with mild or moderate respiratory distress and may reduce the numbers of patients requiring intubation, mechanical ventilation in some severely ill patients such as High flow nasal oxygen (HFNO) High flow nasal oxygen (HFNO) includes high flow nasal cannula and high velocity nasal insufflation. High flow oxygen systems provide oxygen-rich heated humidified gas to the patient's nose at flow levels sufficient to deliver a constant, precisely set high FiO2. Exhalation is to the open air. HFNO reduces dead space, provides low levels of PEEP, and decreases breathing frequency and work of breathing HFNC flow rates reach up to 60 L/min, whereas HVNI delivers flow rates up to 40 L/min due to differing mechanisms of delivery (4).
High velocity nasal insufflation (HVNI) utilizes a small-bore nasal cannula to generate higher velocities of gas delivery than HFNC which uses large bore cannula
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Basma A Mohammed, MD
- Número de telefone: +0201067620044
- E-mail: Basma.20133938@med.au.edu.eg
Estude backup de contato
- Nome: Hoda A Makhlouf, MD
- Número de telefone: +0201001529442
- E-mail: hamakhlouf@yahoo.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- COVID-19 positive by RT-PCR
- Age≥ 18 years
- Both gender
- Classical radiological lesions of COVID-19 on HRCT chest.
- Respiratory rate > 30/ min and not responding to non-rebreather masks.
- COVID-related pneumonia requiring non-invasive ventilatory support (high-flow nasal cannula, and / or non-invasive ventilation and / or CPAP)
Exclusion Criteria:
- Age < 18 years
- Patients who refuse to participate in the study
- Severe respiratory failure requiring invasive ventilatory support
- Indication of immediate tracheal intubation
- Significant acute progressive circulatory insufficiency
- Impaired conscious level
- Nasal blockade
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: High Flow Nasal Cannula
Standard operating procedures represented by high flow nasal cannula oxygen therapy
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• The patient will be allocated into 2 groups, patients who will require ventilatory support via HFNC and those who will require HVNI
|
|
Comparador Ativo: High Velocity Nasal Insufflation
Standard operating procedures represented by high velocity nasal insufflation therapy
|
• The patient will be allocated into 2 groups, patients who will require ventilatory support via HFNC and those who will require HVNI
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
To compare the outcomes of HFNC and HVNI in COVID-19 patients with acute respiratory failure
Prazo: baseline
|
need for mechanical ventilation
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baseline
|
|
changes of arterial blood gases (ABG) parameters
Prazo: within 2 hours then according to clinical condition
|
changes of arterial blood gases (ABG) parameters
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within 2 hours then according to clinical condition
|
|
duration of ventilatory support
Prazo: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
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duration of ventilatory support
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From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
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delay between admission and intubation.
Prazo: baseline
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delay between admission and intubation.
|
baseline
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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To evaluate the length of ICU stay and mortality rate in HFNC versus HVNI in COVID-19 patients
Prazo: baseline
|
duration of ICU stay
|
baseline
|
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mortality rate
Prazo: baseline
|
mortality rate
|
baseline
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Maha k Ghanem, MD, Assuit university, Egypt
Publicações e links úteis
Publicações Gerais
- Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
- Nishimura M. High-Flow Nasal Cannula Oxygen Therapy in Adults: Physiological Benefits, Indication, Clinical Benefits, and Adverse Effects. Respir Care. 2016 Apr;61(4):529-41. doi: 10.4187/respcare.04577.
- Alhazzani W, Moller MH, Arabi YM, Loeb M, Gong MN, Fan E, Oczkowski S, Levy MM, Derde L, Dzierba A, Du B, Aboodi M, Wunsch H, Cecconi M, Koh Y, Chertow DS, Maitland K, Alshamsi F, Belley-Cote E, Greco M, Laundy M, Morgan JS, Kesecioglu J, McGeer A, Mermel L, Mammen MJ, Alexander PE, Arrington A, Centofanti JE, Citerio G, Baw B, Memish ZA, Hammond N, Hayden FG, Evans L, Rhodes A. Surviving Sepsis Campaign: guidelines on the management of critically ill adults with Coronavirus Disease 2019 (COVID-19). Intensive Care Med. 2020 May;46(5):854-887. doi: 10.1007/s00134-020-06022-5. Epub 2020 Mar 28.
- Wang Y, Wang Y, Chen Y, Qin Q. Unique epidemiological and clinical features of the emerging 2019 novel coronavirus pneumonia (COVID-19) implicate special control measures. J Med Virol. 2020 Jun;92(6):568-576. doi: 10.1002/jmv.25748. Epub 2020 Mar 29.
- Doshi P, Whittle JS, Bublewicz M, Kearney J, Ashe T, Graham R, Salazar S, Ellis TW Jr, Maynard D, Dennis R, Tillotson A, Hill M, Granado M, Gordon N, Dunlap C, Spivey S, Miller TL. High-Velocity Nasal Insufflation in the Treatment of Respiratory Failure: A Randomized Clinical Trial. Ann Emerg Med. 2018 Jul;72(1):73-83.e5. doi: 10.1016/j.annemergmed.2017.12.006. Epub 2018 Jan 6.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Antecipado)
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 (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
- HFNC VS HVNI in COVID 19
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