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

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ClinicalTrials.gov Identifier: NCT02331056
Recruitment Status : Completed
First Posted : January 5, 2015
Last Update Posted : October 7, 2016
Sponsor:
Information provided by (Responsible Party):
Hyun Joo Ahn, 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.

Condition or disease Intervention/treatment
Pulmonary Neoplasm Pulmonary Tuberculosis 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.

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

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. Changes from baseline in SVV, SVI after fluid loading [ Time Frame: 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) [ Time Frame: 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 ) [ Time Frame: 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



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02331056


Locations
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Korea, Republic of
Samsung medical center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Hyun Joo Ahn Samsung Medical Center

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hyun Joo Ahn, Associate professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02331056     History of Changes
Other Study ID Numbers: 2014-06-053-002
First Posted: January 5, 2015    Key Record Dates
Last Update Posted: October 7, 2016
Last Verified: October 2016

Keywords provided by Hyun Joo Ahn, Samsung Medical Center:
Stroke volume variation
fluid responsiveness
One-lung ventilation
thoracotomy

Additional relevant MeSH terms:
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Tuberculosis
Tuberculosis, Pulmonary
Lung Neoplasms
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms