Patient Comfort During High Flow Nasal Cannula Versus Nasal Continuous Airway Pressure (CPAP)
Patient Comfort During High Flow Nasal Cannula (HFNC)Versus Nasal Continuous Airway Pressure (CPAP): a Cross Over Randomised Trial
Preterm children are at increased risk for developing lung disease due to immature lungs. Non-invasive ventilation (NIV) support is increasingly used as treatment. Nasal continuous positive airway pressure (nCPAP) is the most common NIV-mode. Recently, high flow nasal cannulas (HFNC) have become an alternative NIV-mode. Both nCPAP and HFNC provide increased pressure in the airways aiming to keep the lungs open. With nCPAP it is common to use short binasal prongs that fill the nostrils completely and are pressed tightly over the nose. With HFNC oxygen/air is administered via two small, thin cannulas located just inside the nostrils, but the nostrils are not blocked.
The aim of this study is to compare patient comfort in premature infants treated with nCPAP and HFNC. The investigators hypothesis is that HFNC increases patient comfort.
The study is a randomized cross over study (2 x 24 hours). Children eligible for inclusion should be born before 34 weeks of gestation and have moderate respiratory distress, thus be "in need" of nCPAP. During the study period (48 hours) the investigators will consider how the child tolerates treatment with nCPAP versus HFNC. Primary outcome is patient comfort assessed with the EDIN-score (Neonatal pain and comfort score). Secondary outcomes are stress hormone response (cortisol in saliva), surrounding noise and parental satisfaction. The child's breathing pattern will be carefully monitored. The study involves no extra painful investigations.
The investigators plan to recruit 20 patients.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Tromsø, Noruega, N-9038
- University Hospital of North Norway
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Preterm infants admitted to the NICU at University Hospital of North Norway, Tromsoe, Norway (single center study)
- Gestational age (GA) < 34 weeks
- Corrected age < 34 weeks
- Receiving nasal CPAP for respiratory distress
- Respiratory "stable": FiO2 < 30%, pCO2 < 8,5 kPa and pH > 7.25.
- GA < 29 weeks: Respiratory "stable" over last 72 h.
- GA 29-33 weeks: Respiratory "stable" over last 24 h.
Exclusion Criteria:
- Congenital anomalies
- Ongoing treatment for hypoglycemia or infection
- Other intercurrent disease requiring frequent blood sampling
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: HFNC
High flow nasal cannula
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In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP
Otros nombres:
In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP
Otros nombres:
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Comparador activo: nCPAP
Nasal CPAP
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In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP
Otros nombres:
In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Patient comfort (EDIN score)
Periodo de tiempo: 48 h (CPAP 24 h and HFNC 24 h); cumulative EDIN score for each 24 epoch is calculated and a change between the two interventions are assessed
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EDIN score (neonatal pain and comfort score) is a validated scoring system to assess pain and comfort in term and preterm infants.
The cumulative EDIN score, based on three evaluations/24 h, is recorded for each 24 h epoch with HFNC or CPAP, respectively.
The change in EDIN score between the two 24 h epochs are assessed.
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48 h (CPAP 24 h and HFNC 24 h); cumulative EDIN score for each 24 epoch is calculated and a change between the two interventions are assessed
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Noise
Periodo de tiempo: Measured at 10 AM and 10 PM over 48 h (4 measurements)
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Surrounding noise (dB)is measured twice daily during the 2 x 24 (48) h study period; twice during CPAP and twice during HFNC.
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Measured at 10 AM and 10 PM over 48 h (4 measurements)
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Parental satisfaction
Periodo de tiempo: Three questions answered after 24 h and 48 h
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3 questions related to parental satisfaction are asked by the end of each 24 h epoch with either CPAP or HFNC.
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Three questions answered after 24 h and 48 h
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Stress hormone response (salivary cortisol)
Periodo de tiempo: Measured at 10 AM and 10 PM over 48 h (4 measurements)
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Salivary cortisol is used as a marker of stress hormone response.
Salivary cortisol is collected twice (10 AM and 10 PM) for every 24 h epoch; a total of 4 measurements.
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Measured at 10 AM and 10 PM over 48 h (4 measurements)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Claus Klingenberg, MD, PhD, University Hospital of North Norway, Tromsø, Norway
Publicaciones y enlaces útiles
Publicaciones Generales
- Wilkinson D, Andersen C, O'Donnell CP, De Paoli AG. High flow nasal cannula for respiratory support in preterm infants. Cochrane Database Syst Rev. 2011 May 11;(5):CD006405. doi: 10.1002/14651858.CD006405.pub2.
- Klingenberg C, Pettersen M, Hansen EA, Gustavsen LJ, Dahl IA, Leknessund A, Kaaresen PI, Nordhov M. Patient comfort during treatment with heated humidified high flow nasal cannulae versus nasal continuous positive airway pressure: a randomised cross-over trial. Arch Dis Child Fetal Neonatal Ed. 2014 Mar;99(2):F134-7. doi: 10.1136/archdischild-2013-304525. Epub 2013 Nov 13.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
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 (Actual)
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
- 2011-2019 REK NORD
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