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

Pulmonary Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02331056
• Other study ID #: 2014-06-053-002
• Status: Completed
• Phase: N/A
• First received: December 15, 2014
• Last updated: October 6, 2016
• Start date: July 2014
• Est. completion date: June 2015

Study information

• Verified date: October 2016
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Neoplasms
• Pulmonary Neoplasm
• Pulmonary Tuberculosis
• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Other:
• fluid loading
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.

Procedure:
• thoracoscopic pulmonary lobectomy
the patient group for scheduled thoracoscopic pulmonary lobectomy
• thoracotomy
the patient group for scheduled open pulmonary lobectomy

Locations

Country	Name	City	State
Korea, Republic of	Samsung medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants with Adverse Events (pulmonary complication)	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	No
Other	Number of Participants with Adverse Events (compromise perfusion of vital organ )	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	No
Primary	Changes from baseline in SVV, SVI after fluid loading	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	No