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Evaluation of PCO2 and PO2 Values in the Pulmonary Artery and Superior Vena Cava

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03591029
Recruitment Status : Completed
First Posted : July 18, 2018
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Franco Cavaliere, Catholic University of the Sacred Heart

Study Description
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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.


Condition or disease Intervention/treatment
Heart Diseases Other: blood samples

Study Design
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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of PCO2 and PO2 Values in the Pulmonary Artery and in the Superior Vena Cava: Relationship With Cardiac Output, Hematocrit and Post Operative Organ Dysfunction
Actual Study Start Date : July 19, 2018
Actual Primary Completion Date : July 23, 2019
Actual Study Completion Date : July 24, 2019
Groups and Cohorts
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Intervention Details:
  • Other: blood samples
    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

Outcome Measures
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Primary Outcome Measures :
  1. PCO2 gap changes [ Time Frame: two days ]
    See if exists a PCO2 pa-svc gap different from zero in patients undergoing cardiac surgery

  2. PO2 gap changes [ Time Frame: two days ]
    See if exists a PCO2 pa-svc gap different from zero in patients undergoing cardiac surgery


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Will be enrolled adult patients only , eligible for cardiac surgery (CABG, valvular replacement, aortic surgery) with extra corporeal circulation.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • severe tricuspid insufficiency
  • EF < 50%
  • SOFA score >1 in at least one of all the criteria
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03591029


Locations
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Italy
catholic University of the sacred Heart
Rome, Italy, 00168
Francesca Bevilacqua
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
More Information
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Responsible Party: Franco Cavaliere, Professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT03591029    
Other Study ID Numbers: Polm01
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases