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

Sponsor
Samsung Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02331056
Collaborator
(none)
79
1
11
7.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: fluid loading
  • Procedure: thoracoscopic pulmonary lobectomy
  • Procedure: 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.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
79 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Could the Stroke Volume Variation Predict a Fluid Responsiveness in Thoracotomy?
Study Start Date :
Jul 1, 2014
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
thoracoscopic pulmonary lobectomy

to observe a fluid responsiveness in patients who receives scheduled thoracoscopic pulmonary lobectomy

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

open pulmonary lobectomy(thoracotomy)

to observe a fluid responsiveness in patients who receives scheduled open pulmonary lobectomy(thoracotomy)

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: thoracotomy
the patient group for scheduled open pulmonary lobectomy

Outcome Measures

Primary Outcome Measures

  1. 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

Other Outcome Measures

  1. Number of Participants with Adverse Events (pulmonary complication) [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.

  2. Number of Participants with Adverse Events (compromise perfusion of vital organ ) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samsung medical center Seoul Korea, Republic of 135-710

Sponsors and Collaborators

  • Samsung Medical Center

Investigators

  • Principal Investigator: Hyun Joo Ahn, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hyun Joo Ahn, Associate professor, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT02331056
Other Study ID Numbers:
  • 2014-06-053-002
First Posted:
Jan 5, 2015
Last Update Posted:
Oct 7, 2016
Last Verified:
Oct 1, 2016
Keywords provided by Hyun Joo Ahn, Associate professor, Samsung Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 7, 2016