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  • Status : Approved
    • First Submitted Date : 2013/06/20
    • Registered Date : 2013/06/21
    • Last Updated Date : 2016/10/06
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1. Background

Background Information
CRIS
Registration Number
KCT0000774 
Unique Protocol ID KUH1160054 
Public/Brief Title Assessment of fluid responsiveness by lung recruitment maneuver in one-lung ventilation 
Scientific Title Assessment of fluid responsiveness by lung recruitment maneuver in one-lung ventilation  
Acronym  
MFDS Regulated Study No
IND/IDE Protocol
Registered
at Other Registry
No
Healthcare Benefit
Approval Status
 

2. Institutional Review Board/Ethics Committee

Institutional Review Board Information
Board Approval Status Submitted approval 
Board Approval Number KHU1160054 
Approval Date 2013-05-30 
Institutional Review Board  
Name Institutional Review Board of Konkuk University Medical Center 
Address  
Telephone  
Data Monitoring Committee No  

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Seong-Hyop Kim 
Title Assistant Professor 
Telephone  
Affiliation Konkuk University Medical Center 
Address 120-1, neungdong-ro, Gwangjin-gu, Seoul, Republic of Korea 
Contact Person for Public Queries
Name Woon-Seok Kang 
Title Assistant Professor 
Telephone  
Affiliation Konkuk University Medical Center 
Address 120-1, neungdong-ro, Gwangjin-gu, Seoul, Republic of Korea 
Contact Person for Updating Information
Name Woon-Seok Kang 
Title Assistant Professor 
Telephone  
Affiliation Konkuk University Medical Center 
Address 120-1, neungdong-ro, Gwangjin-gu, Seoul, Republic of Korea 

4. Status

Status Information
Study Site Single
Overall Recruitment Status Completed  
Date of First Enrollment 2013-06-20 , Actual
Target Number of Participant 80
Primary Completion Date
Study Completion Date
Recruitment Status by Participating Study Site 1
Name of Study Site Konkuk University Medical Center 
Recruitment Status Completed  
Date of First Enrollment 2013-06-20 , Actual

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Konkuk University Medical Center 
Organization Type University  
Project ID KUH1160054 

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Konkuk University Medical Center 
Organization Type University  

7. Study Summary

Study Summary Information
Lay Summary During anesthesia maintenance by using one-lung ventilation, the heart-lung interaction can be different to compared with using two-lung ventilation and the parameters which indicate fluid responsiveness can be different and inaccurate. The aim of this study is to evaluate the accuracy and difference of the parameter which is indicate fluid responsiveness in one-lung ventilation using lung recruitment maneuver.  

8. Study Design

Study Design Information
Study Type Observational Study 
Observational Study Model Case-control 
Time Perspective Prospective    
Target Number of Participant 80
Cohort/Group Number
Cohort/
Group 1
Cohort/Group
Label
Resoponer group 
Cohort/Group
Description
After main surgical procedure and at the time of conversion from one-lung ventilation to two-lung ventilation, lung recruitment maneuver (breath holding with a two-lung ventilation of peak inspiratory pressure 30-40 cmH2O for 10 s, 3 - 4 times) is applied. After 5 minutes of patients' position change from lateral to supine. And then, 10 ml/kg of colloid solution is administrated for 30 minutes. Mean arterial blood pressure, heart rate, cardiac output, cardiac index, storke volume index and stroke volume variation are measured at 1) before lung recruitment maneuver, 2) 1 minute after lung recruitment maneuver, 3) 3 minutes after lung recruitment maneuver, 4) before 10 ml/kg of colloid solution administration and 5) 5 minutes after the end of colloid solution administration. Responder group is defined that the patients showed the increase of stroke volume index above 25% before and after 10 ml/kg colloid solution administration. 
Biospecimen
Collection & Archiving
Not collect nor Archive 
Biospecimen Description  
Cohort/
Group 2
Cohort/Group
Label
Non-responder group 
Cohort/Group
Description
After main surgical procedure and at the time of conversion from one-lung ventilation to two-lung ventilation, lung recruitment maneuver (breath holding with a two-lung ventilation of peak inspiratory pressure 30-40 cmH2O for 10 s, 3 - 4 times) is applied. After 5 minutes of patients' position change from lateral to supine. And then, 10 ml/kg of colloid solution is administrated for 30 minutes. Mean arterial blood pressure, heart rate, cardiac output, cardiac index, storke volume index and stroke volume variation are measured at 1) before lung recruitment maneuver, 2) 1 minute after lung recruitment maneuver, 3) 3 minutes after lung recruitment maneuver, 4) before 10 ml/kg of colloid solution administration and 5) 5 minutes after the end of colloid solution administration. Non-responder group is defined that the patients showed the increase of stroke volume index less than 25% before and after 10 ml/kg colloid solution administration. 
Biospecimen
Collection & Archiving
Not collect nor Archive 
Biospecimen Description  

9. Subject Eligibility

Subject Eligibility Information
Study Population Description The patients received anesthesia management with one-lung ventilation  
Sampling Method After explanations of this study to the patients, the patients who agree this study are paticipated.  
Condition(s)/Problem(s) * Diseases of th respiratory system
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 18 Year ~ 79 Year
Description The patients received anesthesia management with one-lung ventilation  
Exclusion Criteria 1. Emergency surgery <br />2. Patient age &lt; 18 or &gt;= 80 years <br />3. Left or right ventricular dysfunction (ejection fraction &lt; 40%) <br />4. PaO2 / FiO2 ratio &lt; 300 at pre-operative evaluation <br />5. Re-operation due to post-operative bleeding or complication <br />6. Severe hepatic or renal disease <br />7. Preoperative dysrhythmia  
Healthy Volunteers No

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome /Safety/Efficacy 
Primary Outcome(s) 1 
Outcome Mean arterial blood pressur 
Timepoint 1) Before and after lung recruitment maneuver, 2) before and after 10 ml/kg colloid solution administration 
Primary Outcome(s) 2 
Outcome Stroke volume variation 
Timepoint 1) Before and after lung recruitment maneuver, 2) before and after 10 ml/kg colloid solution administration 
Primary Outcome(s) 3 
Outcome Cardiac output 
Timepoint 1) Before and after lung recruitment maneuver, 2) before and after 10 ml/kg colloid solution administration 
Secondary Outcome(s) 1 
Outcome Heart rate 
Timepoint 1) Before and after lung recruitment maneuver, 2) before and after 10 ml/kg colloid solution administration 
Secondary Outcome(s) 2 
Outcome cardiac index 
Timepoint 1) Before and after lung recruitment maneuver, 2) before and after 10 ml/kg colloid solution administration 
Secondary Outcome(s) 3 
Outcome stroke volume index 
Timepoint 1) Before and after lung recruitment maneuver, 2) before and after 10 ml/kg colloid solution administration 

11. Study Results and Publication

Study Results and Publication Information
Result Registered

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information
Sharing Statement Not provided at time of Registration 
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