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

NCT02331056 | Completed DMC

• 1 other identifier: 2014-06-053-002
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Neoplasm; Pulmonary Tuberculosis

Keywords

Stroke volume variation; fluid responsiveness; One-lung ventilation; thoracotomy

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (2)

• Number of Participants with Adverse Events (pulmonary complication)

  participants will be followed for the duration of hospital stay, an expected average of 1 week

• 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

Study Arms (2)

thoracoscopic pulmonary lobectomy

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

Other: fluid loading; Procedure: thoracoscopic pulmonary lobectomy

open pulmonary lobectomy(thoracotomy)

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

Other: fluid loading; Procedure: thoracotomy

Interventions

fluid loading OTHER

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.

open pulmonary lobectomy(thoracotomy); thoracoscopic pulmonary lobectomy

thoracoscopic pulmonary lobectomy PROCEDURE

the patient group for scheduled thoracoscopic pulmonary lobectomy

thoracoscopic pulmonary lobectomy

thoracotomy PROCEDURE

the patient group for scheduled open pulmonary lobectomy

open pulmonary lobectomy(thoracotomy)

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• The patients scheduled for pulmonary lobectomy with one lung ventilation by lung cancer, nodule, or pulmonary tuberculosis under thoracoscopy or thoracotomy in our hospital

You may not qualify if:

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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung medical center

Seoul, 135-710, South Korea

Location

Related Publications (1)

• 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.

  PMID: 28504996 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Tuberculosis, Pulmonary

Interventions

Thoracotomy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections

Intervention Hierarchy (Ancestors)

Thoracic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Hyun Joo Ahn

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: January 5, 2015
• Study Start: July 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 7, 2016

Record last verified: 2016-10

Locations

KR (1)