Use of High Flows in Pediatric Cardiac Surgical Patients
Use of High Flow Ventilation in Pediatric Cardiac Surgical Patients
Humidified high flow nasal prong oxygen therapy is a method for providing oxygen and CPAP. The delivery of high flows decreases dilution of the inhaled oxygen and, by matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole inspiratory phase. In addition, a flow-dependent effect of continuous positive airway pressure, possibly due to an air entrainment mechanism, has been documented in healthy volunteers and in patients with COPD.
The investigators working hypothesis is that the use of post-extubation CPAP delivered via nasal cannulae in infants less than 18 months, post-bypass surgery will have better PaCO2 values than infants extubated on to oxygen therapy.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
After CICU admission, infants with no bleeding, normothermic and hemodynamically stable will be switched from PRVC to SIMV+PSV (10-15cmH20) which should be maintained for 4 hours. An arterial gas analysis will be performed after 20 minutes. Infants with normal gas-exchange are gradually weaned from mechanical ventilation At each weaning step an arterial hemogasanalysis is performed after 20 minutes, to assess if the decreased ventilatory support is tolerated. Increased work of breathing and respiratory acidosis (ph< 7.3 or pCO2 > 60 mmHg) are considered criteria to withhold the weaning process. After a 4 hour period on SIMV+PSV the child should be switched to PSV for 30 minutes and then extubated. The following extubation criteria should be reached:
- Satisfactory blood gases with PCO2 under 45mmHg, pH greater than 7.30.
- Fractional inspired oxygen concentration of 65% and or less than the baseline value
- Adequate respiratory frequency according to age without dyspnea
At this point criteria for extubation are reached. Once extubation has taken place the child will be placed either on traditional oxygen therapy or high flow nasal cannulae according to randomization.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Rome, Italia, 00165
- Reclutamiento
- Ospedale Bambino Gesù
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Contacto:
- Francesca G Iodice, M.D.
- Número de teléfono: 2449 0039066859
- Correo electrónico: francesca_iodice@yahoo.it
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Investigador principal:
- Francesca Iodice, M.D.
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Rome, Italia, 00195
- Reclutamiento
- Francesca Iodice
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Contacto:
- Francesca Iodice, MD
- Número de teléfono: 393336545045
- Correo electrónico: fgiovanna.iodice@opbg.net
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Contacto:
- Francesca Iodice
- Número de teléfono: 393336545045
- Correo electrónico: francesca_iodice@yahoo.it
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Sub-Investigador:
- Giuseppina Testa, MD
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Sub-Investigador:
- Vincenzo Vitale, MD
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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:
- Age: 0-18 months
- Mechanical Ventilation via an endotracheal tube
- Elective surgery
- Post-bypass procedure
- Rachs 2 and above
Exclusion Criteria:
- Presence of major congenital malformations
- Presence of neuromuscular disease
- Presence of non drained pneumothorax
- Absent respiratory drive or recurrent apneas
- Hemodynamic instability
- Glasgow coma score (GCS) less than 8
- ECG with evidence of ischaemia or arrhythmias
- Active bleeding
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: High flows
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Once extubation has taken place the child will be placed either on traditional oxygen therapy or high flow nasal cannulae according to randomization.
Otros nombres:
Once extubation has taken place the child will be placed either on traditional oxygen therapy or high flow nasal cannulae according to randomization.
Otros nombres:
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Otro: oxygen therapy
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Once extubation has taken place the child will be placed either on traditional oxygen therapy or high flow nasal cannulae according to randomization.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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The primary aim of this study is to show an improvement of the average levels of postextubation PaCO2 in infants less than 18 months of age and post-bypass surgery
Periodo de tiempo: Final outcome measure is assessed when 80 patients have been recruited.Outcome measure is assessed at the end of 48 hours postextubation and when the patient is discharged from the ICU.
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Final outcome measure is assessed when 80 patients have been recruited.Outcome measure is assessed at the end of 48 hours postextubation and when the patient is discharged from the ICU.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The secondary aim is to verify the reintubation rate between the two groups.
Periodo de tiempo: Final outcome measure is assessed when 80 patients have been recruited.Outcome measure is assessed at the end of 48 hours postextubation and when the patient is discharged from the ICU.
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Other points that will be evaluated are: the improvement of X-ray findings, the length of ICU stay and the development of complications such as nasal ulcers and gastric distension.
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Final outcome measure is assessed when 80 patients have been recruited.Outcome measure is assessed at the end of 48 hours postextubation and when the patient is discharged from the ICU.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Francesca Iodice, MD, Ospedale Bambino Gesu'
Publicaciones y enlaces útiles
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BambinoGHRI
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