- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01873261
NIV NAVA Versus NIV-PS in Pediatric Patients - Pilot Study (NINAVAPed)
Neurally Adjusted Ventilatory Assist (NAVA) Versus Pressure Support in Pediatric Acute Respiratory Failure - Pilot Study
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This pilot study will be an observational no randomize study in which the NiNAVAped protocol will be applied solely to the NIV NAVA arm.
Every PICU will have to include 3 patients in the Pilot study before starting the clinical trial, which means that the pilot study will involve a maximum of 60 patients.
Should the Pilot study reveal deficiencies in the NiNAVAped design, the protocol would be improved accordingly.
There will be a specific consent document during the Pilot study. The Pilot study will be published in a scientific journal.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Pedro De la Oliva, MD, PhD
- Número de teléfono: +347277149
- Correo electrónico: poliva.hulp@salud.madrid.org
Ubicaciones de estudio
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Madrid, España, 28046
- Reclutamiento
- Hospital Universitario La Paz
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Contacto:
- Pedro De la Oliva, MD,PhD
- Número de teléfono: 0034917277149
- Correo electrónico: poliva.hulp@salud.madrid.org
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Investigador principal:
- Pedro De la Oliva, MD, PhD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Age: > 1 month age to 18 years
- Moderate/severe Pediatric Acute Respiratory failure of any origin evaluated after a period of respiratory stabilization (aspiration of secretions, physiotherapy, oxygen and nebulized therapy) when the attending pediatric intensive care physician believes that the patient is likely to require endotracheal intubation (ETI).
- Non intubated
- Admitted to the PICU
- Minimally agitated/sedated: between -2 and +2 on the Richmond agitation-sedation scale (Table 2)
Exclusion Criteria:
- Patients younger than 1 month or older than 18 year
- Patients who need immediate endotracheal intubation: i.e.: Severe ARF with signs of exhaustion
- Facial trauma/burns
- Recent facial, upper way, or upper gastrointestinal tract surgery excepting gastrostomy for feeding
- Fixed obstruction of the upper airway
- Inability to protect airway
- Life threatening hypoxemia defined as SpaO2 <90% with FiO2 > 0.8 on hi-flow oxygen.
- Hemodynamic instability: refractory at volume expansion >60 ml/kg and dopamine >10 mcg/kg/min
- Impaired consciousness defined as Glasgow coma scale < 10.
- Bowel obstruction.
- Untreated pneumothorax.
- Poor short term prognosis (high risk of death in the next 3 months)
- Known esophageal problem (hiatal hernia, esophageal varicosities)
- Active upper gastro-intestinal bleeding or any other contraindication to the insertion of a NG tube.
- Neuromuscular disease
- Vomiting
- Cough or gag reflex impairment.
- Cyanotic congenital heart disease.
- Complete absence of cooperation
- This patient has been included (randomized) previously in the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Avoiding endotracheal intubation using non-invasive ventilation
Periodo de tiempo: During non invasive ventilation, an average of 2-3 days.
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The primary endpoint of this study is avoiding endotracheal intubation (ETI) (and conventional mechanical ventilation (MV)) using non-invasive ventilation (NIV).
It is defined as no need for ETI (and MV) for at least 48h after the withdrawal of NIV.
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During non invasive ventilation, an average of 2-3 days.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Length (days) of endotracheal intubation (conventional mechanical ventilation) after NIV
Periodo de tiempo: During mechanical ventilation after NIV
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During mechanical ventilation after NIV
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Length (days) of PICU stay after NIV
Periodo de tiempo: After NIV
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The patients will be follow up after NIV during the PICU stay, and average of two weeks
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After NIV
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Length (days) hospital stay after NIV
Periodo de tiempo: After NIV
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The patients will be follow up after NIV during hospital stay, an average of 2-3 weeks.
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After NIV
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jesús Villar, MD, PhD, Hospital Universitario Dr. Negrin
- Director de estudio: Robert M Kacmarek, PhD RRT FCCM, Massachusetts General Hospital, Boston, USA
Publicaciones y enlaces útiles
Publicaciones Generales
- Breatnach C, Conlon NP, Stack M, Healy M, O'Hare BP. A prospective crossover comparison of neurally adjusted ventilatory assist and pressure-support ventilation in a pediatric and neonatal intensive care unit population. Pediatr Crit Care Med. 2010 Jan;11(1):7-11. doi: 10.1097/PCC.0b013e3181b0630f.
- Calderini E, Chidini G, Pelosi P. What are the current indications for noninvasive ventilation in children? Curr Opin Anaesthesiol. 2010 Jun;23(3):368-74. doi: 10.1097/ACO.0b013e328339507b.
- Essouri S, Durand P, Chevret L, Haas V, Perot C, Clement A, Devictor D, Fauroux B. Physiological effects of noninvasive positive ventilation during acute moderate hypercapnic respiratory insufficiency in children. Intensive Care Med. 2008 Dec;34(12):2248-55. doi: 10.1007/s00134-008-1202-9. Epub 2008 Aug 19.
- Keenan SP, Sinuff T, Cook DJ, Hill NS. Does noninvasive positive pressure ventilation improve outcome in acute hypoxemic respiratory failure? A systematic review. Crit Care Med. 2004 Dec;32(12):2516-23. doi: 10.1097/01.ccm.0000148011.51681.e2.
- Cheifetz IM. Invasive and noninvasive pediatric mechanical ventilation. Respir Care. 2003 Apr;48(4):442-53; discussion 453-8.
- Al-Mutairi SS, Al-Deen JS. Non-invasive positive pressure ventilation in acute respiratory failure. An alternative modality to invasive ventilation at a general hospital. Saudi Med J. 2004 Feb;25(2):190-4.
- L'HerE, Moriconi M, Texier F, Bouquin V, Kaba L, Renault A, Garo B, Boles JM. Non-invasive continuous positive airway pressure in acute hypoxaemic respiratory failure--experience of an emergency department. Eur J Emerg Med. 1998 Sep;5(3):313-8.
- Bernet V, Hug MI, Frey B. Predictive factors for the success of noninvasive mask ventilation in infants and children with acute respiratory failure. Pediatr Crit Care Med. 2005 Nov;6(6):660-4. doi: 10.1097/01.pcc.0000170612.16938.f6.
- Kendirli T, Kavaz A, Yalaki Z, Ozturk Hismi B, Derelli E, Ince E. Mechanical ventilation in children. Turk J Pediatr. 2006 Oct-Dec;48(4):323-7.
- Biban P, Serra A, Polese G, Soffiati M, Santuz P. Neurally adjusted ventilatory assist: a new approach to mechanically ventilated infants. J Matern Fetal Neonatal Med. 2010 Oct;23 Suppl 3:38-40. doi: 10.3109/14767058.2010.510018.
- Munoz-Bonet JI, Flor-Macian EM, Brines J, Rosello-Millet PM, Cruz Llopis M, Lopez-Prats JL, Castillo S. Predictive factors for the outcome of noninvasive ventilation in pediatric acute respiratory failure. Pediatr Crit Care Med. 2010 Nov;11(6):675-80. doi: 10.1097/PCC.0b013e3181d8e303.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HULP-PI-3750
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