Difference Between Central and Peripheral Arterial Blood Oxygen Saturation With Different CPB Strategy
Recruitment status was Not yet recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 25, 2012 | ||||||||
| Last Updated Date | September 29, 2012 | ||||||||
| Start Date ICMJE | October 2012 | ||||||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: Yes ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01698853 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Difference Between Central and Peripheral Arterial Blood Oxygen Saturation With Different CPB Strategy | ||||||||
| Official Title ICMJE | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | 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 |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||
| Estimated Completion Date | May 2013 | ||||||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | China | ||||||||
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| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01698853 | ||||||||
| Other Study ID Numbers ICMJE | 192837 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Xijing Hospital | ||||||||
| Study Sponsor ICMJE | Xijing Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Xijing Hospital | ||||||||
| Verification Date | September 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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