Evaluation of PCO2 and PO2 Values in the Pulmonary Artery and Superior Vena Cava
1 other identifier
observational
50
1 country
2
Brief Summary
The study is about comparing blood samples obtained from the superior vena cava and the pulmonary artery. The investigators will compare the values of PCO2 and PO2 from these two sites, in order to see if exists a PCO2 gap and a PO2 gap, different from zero. Moreover the investigators want to find out if these gaps are related with changes in the cardiac output, the hematocrit or if they can predict post operative dysfunctions. Blood samples will be taken at six different times as scheduled by the protocol. Along with the two venous blood samples, an arterial blood sample will be taken too, from a radial of femoral artery catheter.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2018
Shorter than P25 for all trials
2 active sites
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
July 2, 2018
CompletedFirst Posted
Study publicly available on registry
July 18, 2018
CompletedStudy Start
First participant enrolled
July 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 24, 2019
CompletedJuly 31, 2019
July 1, 2019
1 year
July 2, 2018
July 30, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
PCO2 gap changes
See if exists a PCO2 pa-svc gap different from zero in patients undergoing cardiac surgery
two days
PO2 gap changes
See if exists a PCO2 pa-svc gap different from zero in patients undergoing cardiac surgery
two days
Interventions
blood samples will be obtained from the superior vena cava (via centra venous catheter), from the pulmonary artery (via Swan Ganz catheter), and from a radial or femoral artery catheter
Eligibility Criteria
Will be enrolled adult patients only , eligible for cardiac surgery (CABG, valvular replacement, aortic surgery) with extra corporeal circulation.
You may qualify if:
- age \> 18 years
- patient undergoing cardiac surgery with extracorporeal circulation
- hemodynamic monitoring with a central venous catheter and a Swan Ganz catheter placed in the internal left giugulare vein
You may not qualify if:
- severe tricuspid insufficiency
- EF \< 50%
- SOFA score \>1 in at least one of all the criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
catholic University of the sacred Heart
Rome, 00168, Italy
Francesca Bevilacqua
Rome, 00168, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 2, 2018
First Posted
July 18, 2018
Study Start
July 19, 2018
Primary Completion
July 23, 2019
Study Completion
July 24, 2019
Last Updated
July 31, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share