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Could the Stroke Volume Variation Predict a Fluid Responsiveness in Thoracotomy?

6 de octubre de 2016 actualizado por: Hyun Joo Ahn, Samsung Medical Center
There are some risks of pulmonary edema in patients undergoing pulmonary lobectomy with one lung ventilation. The overloading of fluid administration could be related to the development of pulmonary edema in patents after thoracic surgery. But fluid restriction may cause major organ hypoperfusion during the surgery. The purpose of this study is to evaluate the ability of stroke volume variation as an indicator for a fluid responsiveness in patient who receives pulmonary lobectomy via thoracotomy.

Descripción general del estudio

Descripción detallada

Perioperative fluid management during thoracic surgery is a significantly important, because it is quite difficult to prevent pulmonary edema due to the fluid overload and compromise perfusion of vital organ. So, it is essential to maintain optimal organ perfusion by appropriate fluid management during thoracic surgery. Stroke volume variation (SVV) is derived from pulse contour analysis and it is known that SVV ≥12~15% correlate with fluid responsiveness, defined as a significant increase in cardiac output with fluid loading, dung two-lung ventilation. It is a parameter derived from changes in stroke volume (SV) that is according to the heart-lung interaction during mechanical ventilation. positive pressure ventilation induces cyclic changes in left ventricular SV that are related mainly to the expiratory decrease in right ventricular filling and ejection. This is a reflected by variations in the SV. However both ventilator issues, such as tidal volume, PEEP, chest and lung condition, and the cardiovascular condition, such as heart rate, rhythm, ventricular function, cardiac afterload, arterial compliance may affect SVV. Recently some studies reported that SVV could predict fluid responsiveness in mechanically ventilated patients under various conditions. But it is still unclear whether SVV could predict fluid responsiveness during one lung ventilation with the chest open via a thoracotomy. During one-lung ventilation, the shunted blood flow through the non-ventilated-lung dose not contribute to the generation of SVV. And with the chest opening by thoracotomy, the pressure generated by ventilator would not be transmitted to the pulmonary vessels but rather to the atmosphere. So, the purpose of this study is to evaluate the ability of SVV as an indicator a fluid responsiveness particularly in patients undergoing one-lung ventilation with thoracotomy and to found the optimal threshold value of SVV for fluid management during thoracic surgery.

Tipo de estudio

De observación

Inscripción (Actual)

79

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

20 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

The patients scheduled for pulmonary lobectomy with one lung ventilation by lung cancer, nodule, or pulmonary tuberculosis under thoracoscopy or thoracotomy in our hospital were included.

Descripción

Inclusion Criteria:

  • The patients scheduled for pulmonary lobectomy with one lung ventilation by lung cancer, nodule, or pulmonary tuberculosis under thoracoscopy or thoracotomy in our hospital

Exclusion Criteria:

  • The patients with known cardiac disease include arrythmia
  • American society of anesthesia physical status III, IV, V

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
thoracoscopic pulmonary lobectomy
to observe a fluid responsiveness in patients who receives scheduled thoracoscopic pulmonary lobectomy

Fluid loading at defined period

  • 500ml colloid solution infusion at 20min after thorax open for 30min. 500ml colloid administration is a kind of routine procedure during pulmonary lobectomy in our hospital. We just control the fluid loading timing for hemodynamic parameter records.
the patient group for scheduled thoracoscopic pulmonary lobectomy
open pulmonary lobectomy(thoracotomy)
to observe a fluid responsiveness in patients who receives scheduled open pulmonary lobectomy(thoracotomy)

Fluid loading at defined period

  • 500ml colloid solution infusion at 20min after thorax open for 30min. 500ml colloid administration is a kind of routine procedure during pulmonary lobectomy in our hospital. We just control the fluid loading timing for hemodynamic parameter records.
the patient group for scheduled open pulmonary lobectomy

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes from baseline in SVV, SVI after fluid loading
Periodo de tiempo: 20min after thorax open and immediate after fluid loading for 30min
we are going to measure the SVV, SVI before and after fluid loading. Fluid responders were defined as patients demonstrating an increase in SVI ≥ 10% and non-responders as patients whose SVI changed < 10%. Receiver operating characteristic (ROC) curves were generated for SVV of each group (responders and non responders). Threshold value of SVV was determined by considering values that yielded the greatest sensitivity and specificity from ROC curve
20min after thorax open and immediate after fluid loading for 30min

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants with Adverse Events (pulmonary complication)
Periodo de tiempo: participants will be followed for the duration of hospital stay, an expected average of 1 week
after surgery check chest x-ray It's the routine follow up after lobectomy.
participants will be followed for the duration of hospital stay, an expected average of 1 week
Number of Participants with Adverse Events (compromise perfusion of vital organ )
Periodo de tiempo: participants will be followed for the duration of hospital stay, an expected average of 1 week
check perioperative urine output, and check post op serum creatine
participants will be followed for the duration of hospital stay, an expected average of 1 week

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Hyun Joo Ahn, Samsung Medical Center

Publicaciones y enlaces útiles

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Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de julio de 2014

Finalización primaria (Actual)

1 de junio de 2015

Finalización del estudio (Actual)

1 de junio de 2015

Fechas de registro del estudio

Enviado por primera vez

15 de diciembre de 2014

Primero enviado que cumplió con los criterios de control de calidad

1 de enero de 2015

Publicado por primera vez (Estimar)

5 de enero de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

7 de octubre de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

6 de octubre de 2016

Última verificación

1 de octubre de 2016

Más información

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