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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05216640
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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Basma A Mohammed, MD
- Número de teléfono: +0201067620044
- Correo electrónico: Basma.20133938@med.au.edu.eg
Copia de seguridad de contactos de estudio
- Nombre: Hoda A Makhlouf, MD
- Número de teléfono: +0201001529442
- Correo electrónico: hamakhlouf@yahoo.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: High Flow Nasal Cannula
Standard operating procedures represented by high flow nasal cannula oxygen therapy
|
• The patient will be allocated into 2 groups, patients who will require ventilatory support via HFNC and those who will require HVNI
|
|
Comparador activo: 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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
To compare the outcomes of HFNC and HVNI in COVID-19 patients with acute respiratory failure
Periodo de tiempo: baseline
|
need for mechanical ventilation
|
baseline
|
|
changes of arterial blood gases (ABG) parameters
Periodo de tiempo: within 2 hours then according to clinical condition
|
changes of arterial blood gases (ABG) parameters
|
within 2 hours then according to clinical condition
|
|
duration of ventilatory support
Periodo de tiempo: 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
|
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
|
|
delay between admission and intubation.
Periodo de tiempo: baseline
|
delay between admission and intubation.
|
baseline
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
To evaluate the length of ICU stay and mortality rate in HFNC versus HVNI in COVID-19 patients
Periodo de tiempo: baseline
|
duration of ICU stay
|
baseline
|
|
mortality rate
Periodo de tiempo: baseline
|
mortality rate
|
baseline
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Maha k Ghanem, MD, Assuit university, Egypt
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Infecciones por coronavirus
- Infecciones por coronaviridae
- Infecciones por Nidovirales
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones del Tracto Respiratorio
- Enfermedades de las vías respiratorias
- Trastornos de la respiración
- Neumonía Viral
- Neumonía
- Enfermedades pulmonares
- COVID-19
- Insuficiencia respiratoria
Otros números de identificación del estudio
- HFNC VS HVNI in COVID 19
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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