Difference Between Central and Peripheral Arterial Blood Oxygen Saturation With Different CPB Strategy

Tracking Information
First Submitted Date	September 25, 2012
First Posted Date	October 3, 2012
Last Update Posted Date	October 3, 2012
Study Start Date	October 2012
Estimated Primary Completion Date	March 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: September 29, 2012)	The difference between peripheral arterial oxygenation and aortic root blood oxygenation [ Time Frame: patients will be followed up during the cardiopulmonary bypass. Blood samples will be collected at 3 timepoints which is specified in the DESCRIPTION ]; The three time points for blood sample collection are:1.right before clamping the aorta; 2.Three minutes after **** without ventilation;3.5 min after re-initiate mechanical ventilation.
Original Primary Outcome Measures	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Difference Between Central and Peripheral Arterial Blood Oxygen Saturation With Different CPB Strategy
Official Title	The Difference Between Central and Peripheral Arterial Blood Oxygen Saturation in Patients Undergoing Cardiac Surgery With Different Cardiopulmonary Bypass Strategy
Brief Summary	Femoro-femoral cardiopulmonary bypass with retrograde perfusion is needed for totally thoracoscopic cardiac surgery. one of the major complication of retrograde perfusion is organ hypoperfusion. Arterial blood gas analysis can help to detect hypoperfusion or hypoxia during retrograde perfusion. However,whether the arterial oxygenation status from different parts of the body are the same in the condition of retrograde perfusion have not been studied. The present study is aimed to determine if there is difference in the arterial oxygenation between peripheral arterial and aortic root during the period of retrograde perfusion.In addition, the impact of artificial ventilation on the difference of arterial oxygenation will also be investigated.
Detailed Description	All patients included will be assigned into two different groups according to the surgical approach,one group is named "NP" with normal perfusion,and the other is named "RP" with retrograde perfusion. For all the patients,we will obtain 0.5ml blood from both peripheral arterial and aortic root for blood gas analysis at some specific time points. We will focus on the differences of arterial oxygenation between peripheral arterial and aortic root at each group.At the same time,we will analyse the impact of artificial ventilation on it.
Study Type	Observational
Study Design	Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	patient undergoing totally thoracoscopic cardiac surgery with cardiopulmonary bypass
Condition	Bypass Complications; Disorder of Blood Gas
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Unknown status
Estimated Enrollment; (submitted: September 29, 2012)	60
Original Estimated Enrollment	Same as current
Estimated Study Completion Date	May 2013
Estimated Primary Completion Date	March 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria	Inclusion Criteria: age > 18 years old; undergoing totally thoracoscopic cardiac surgery with cardiopulmonary bypass Exclusion Criteria: without informed consent; pregnancy
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	China
Removed Location Countries
Administrative Information
NCT Number	NCT01698853
Other Study ID Numbers	192837
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Xijing Hospital
Study Sponsor	Xijing Hospital
Collaborators	Not Provided
Investigators	Study Chair: Hailong Dong, Doctor department director
PRS Account	Xijing Hospital
Verification Date	September 2012