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

• Sponsor: Catholic University of the Sacred Heart (Other)
• Overall Status: Completed
• CT.gov ID: NCT03591029
• Collaborator: (none)
• Enrollment: 50
• Locations: 2
• Actual Duration (Months): 12.2
• Patients Per Site: 25
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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	Phase
Heart Diseases	Other: blood samples

Study Design

• 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: Jul 19, 2018
• Actual Primary Completion Date: Jul 23, 2019
• Actual Study Completion Date: Jul 24, 2019

Outcome Measures

Primary Outcome Measures

1. PCO2 gap changes [two days]

   See if exists a PCO2 pa-svc gap different from zero in patients undergoing cardiac surgery

2. PO2 gap changes [two days]

   See if exists a PCO2 pa-svc gap different from zero in patients undergoing cardiac surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	catholic University of the sacred Heart	Rome		Italy	00168
2	Francesca Bevilacqua	Rome		Italy	00168

Sponsors and Collaborators

• Catholic University of the Sacred Heart

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Franco Cavaliere, Professor, Catholic University of the Sacred Heart
• ClinicalTrials.gov Identifier: NCT03591029
• Other Study ID Numbers: Polm01
• First Posted: Jul 18, 2018
• Last Update Posted: Jul 31, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heart Diseases

Study Results

No Results Posted as of Jul 31, 2019