NCT01698853

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2012

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

October 3, 2012

Status Verified

September 1, 2012

Enrollment Period

5 months

First QC Date

September 25, 2012

Last Update Submit

September 29, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    patients will be followed up during the cardiopulmonary bypass. Blood samples will be collected at 3 timepoints which is specified in the DESCRIPTION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patient undergoing totally thoracoscopic cardiac surgery with cardiopulmonary bypass

You may qualify if:

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

You may not qualify if:

  • without informed consent
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Study Officials

  • Hailong Dong, Doctor

    department director

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2012

First Posted

October 3, 2012

Study Start

October 1, 2012

Primary Completion

March 1, 2013

Study Completion

May 1, 2013

Last Updated

October 3, 2012

Record last verified: 2012-09

Locations