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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2012 by Xijing Hospital
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01698853
First received: September 25, 2012
Last updated: September 29, 2012
Last verified: September 2012
  Purpose

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.


Condition
Bypass Complications
Disorder of Blood Gas

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Difference Between Central and Peripheral Arterial Blood Oxygen Saturation in Patients Undergoing Cardiac Surgery With Different Cardiopulmonary Bypass Strategy

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: October 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patient undergoing totally thoracoscopic cardiac surgery with cardiopulmonary bypass

Criteria

Inclusion Criteria:

  • age > 18 years old
  • undergoing totally thoracoscopic cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

  • without informed consent
  • pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698853

Contacts
Contact: Min Chen, M.D. 86-13991221157 chenminh@yahoo.com.cn
Contact: Jing Zhao, M.D. 86-13892810471 zhaojing939699@126.com

Locations
China, Shaanxi
Department of Anesthesiology, Xijing Hospital Not yet recruiting
Xi'an, Shaanxi, China, 710032
Contact: Min Chen, M.D.    86-13991221157    chenminh@yahoo.com.cn   
Contact: Jing Zhao, M.D.    86-13892810471    zhaojing939699@126.com   
Principal Investigator: Hailong Dong, M.D., PhD.         
Sponsors and Collaborators
Xijing Hospital
Investigators
Study Chair: Hailong Dong, Doctor department director
  More Information

No publications provided

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT01698853     History of Changes
Other Study ID Numbers: 192837
Study First Received: September 25, 2012
Last Updated: September 29, 2012
Health Authority: China: Ethics Committee

ClinicalTrials.gov processed this record on August 19, 2014