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

Heart Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03591029
• Other study ID #: Polm01
• Status: Completed
• Start date: July 19, 2018
• Est. completion date: July 24, 2019

Study information

• Verified date: July 2019
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 24, 2019
• Est. primary completion date: July 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases

Intervention

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

Locations

Country	Name	City	State
Italy	catholic University of the sacred Heart	Rome
Italy	Francesca Bevilacqua	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PCO2 gap changes	See if exists a PCO2 pa-svc gap different from zero in patients undergoing cardiac surgery	two days
Primary	PO2 gap changes	See if exists a PCO2 pa-svc gap different from zero in patients undergoing cardiac surgery	two days