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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Diseases
• Intervention / Treatment: Other: blood samples

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00168
    • Catholic University of the Sacred Heart
  • Rome, Italy, 00168
    • Francesca Bevilacqua

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 19, 2018
• Primary Completion (ACTUAL): July 23, 2019
• Study Completion (ACTUAL): July 24, 2019

Study Registration Dates

• First Submitted: July 2, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (ACTUAL): July 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 30, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: Polm01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No