Bypass ComplicationsNCT01698853
Difference Between Central and Peripheral Arterial Blood Oxygen Saturation With Different CPB Strategy
An observational study of Bypass Complications and Disorder of Blood Gas, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bypass Complications, Disorder of Blood Gas
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Oct 2012to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient undergoing totally thoracoscopic cardiac surgery with cardiopulmonary bypass
Who may be able to join
- age > 18 years old
- undergoing totally thoracoscopic cardiac surgery with cardiopulmonary bypass
Who cannot join
- without informed consent
- pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, Xijing Hospital
Xi'an, Shaanxi, 710032
Min Chen, M.D., 86-13991221157, chenminh@yahoo.com.cn
Jing Zhao, M.D., 86-13892810471, zhaojing939699@126.com
About this study
Official title: The Difference Between Central and Peripheral Arterial Blood Oxygen Saturation in Patients Undergoing Cardiac Surgery With Different Cardiopulmonary Bypass Strategy
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.
Read the 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.
- Conditions
- Bypass Complications, Disorder of Blood Gas
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between peripheral arterial oxygenation and aortic root blood oxygenation
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.
Measured: patients will be followed up during the cardiopulmonary bypass. Blood samples will be collected at 3 timepoints which is specified in the DESCRIPTION
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bypass ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hailong Dong, Doctor, Study chair, department director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698853
- Sponsor's protocol ID
- 192837
- Status last verified
- Sep 2012
- First submitted
- 25 Sep 2012
- Last updated
- 3 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Difference Between Central and Peripheral Arterial Blood Oxygen Saturation in Patients Undergoing Cardiac Surgery With Different Cardiopulmonary Bypass Strategy
- ClinicalTrials.gov ID
- NCT01698853
- Acronym / sponsor ID
- 192837
- Conditions
- Bypass Complications, Disorder of Blood Gas
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 3 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient undergoing totally thoracoscopic cardiac surgery with cardiopulmonary bypass
Key inclusion criteria (2 listed)
- age > 18 years old
- undergoing totally thoracoscopic cardiac surgery with cardiopulmonary bypass
Key exclusion criteria (2 listed)
- without informed consent
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hailong Dong, Doctor study chair
department director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bypass Complications and Disorder of Blood Gas, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Chen, M.D. (86-13991221157, chenminh@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2012.