Clinical trial NCT02331056: Could the Stroke Volume Variation Predict a Fluid Responsiveness in Thoracotomy?
Official title: Could the Stroke Volume Variation Predict a Fluid Responsiveness in Thoracotomy?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Neoplasm
Pulmonary Tuberculosis
Keywords: Stroke volume variation
fluid responsiveness
One-lung ventilation
thoracotomy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-01-05
Enrollment: 79
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes from baseline in SVV, SVI after fluid loading
timeFrame: 20min after thorax open and immediate after fluid loading for 30min
Secondary outcomes:
Other outcomes:
measure: Number of Participants with Adverse Events (pulmonary complication)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: Number of Participants with Adverse Events (compromise perfusion of vital organ )
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 1 week
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
Study officials:
affiliation: Samsung Medical Center
name: Hyun Joo Ahn
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jeong DM, Ahn HJ, Park HW, Yang M, Kim JA, Park J. Stroke Volume Variation and Pulse Pressure Variation Are Not Useful for Predicting Fluid Responsiveness in Thoracic Surgery. Anesth Analg. 2017 Oct;125(4):1158-1165. doi: 10.1213/ANE.0000000000002056.