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

Completed

• Conditions: Pulmonary Neoplasm; Pulmonary Tuberculosis
• Interventions: Other: fluid loading; Procedure: thoracotomy; Procedure: thoracoscopic pulmonary lobectomy

• Registration Number: NCT02331056
• Lead Sponsor: Samsung Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-12-15
• Study First Submitted QC: 2015-01-01
• Study First Posted: 2015-01-05
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-06
• Last Update Posted: 2016-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
open pulmonary lobectomy(thoracotomy)	thoracotomy	to observe a fluid responsiveness in patients who receives scheduled open pulmonary lobectomy(thoracotomy)
thoracoscopic pulmonary lobectomy	thoracoscopic pulmonary lobectomy	to observe a fluid responsiveness in patients who receives scheduled thoracoscopic pulmonary lobectomy
thoracoscopic pulmonary lobectomy	fluid loading	to observe a fluid responsiveness in patients who receives scheduled thoracoscopic pulmonary lobectomy
open pulmonary lobectomy(thoracotomy)	fluid loading	to observe a fluid responsiveness in patients who receives scheduled open pulmonary lobectomy(thoracotomy)

Primary Outcome Measures

Name	Time	Method
Changes from baseline in SVV, SVI after fluid loading	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

Trial Locations

Locations (1)

Samsung medical center; 🇰🇷 Seoul, Korea, Republic of