Comparing Air Embolic Load in Two Venous Cannulation Methods, 40 Patients Undergoing Elective Valve Surgery.

Extracorporeal Circulation; Complications Clinical Trial

Official title:

Does Venous Cannulation Method Affect Air Embolic Load to the Patient During Extracorporeal Circulation?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05820828
• Other study ID #: 2023-00204-01
• Status: Completed
• Phase: N/A
• Start date: April 21, 2023
• Est. completion date: August 28, 2023

Study information

• Verified date: April 2024
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this single center prospective controlled observational and interventional trial is to investigate and compare origin of air emboli when different venous cannulation methods is used in patients undergoing cardiac surgery with extracorporeal circulation.

40 consecutive elective patients will be included in two groups, depending on the procedure requiring bicaval or cavoatrial cannulation. After assorted into respective group, patients will be block randomized (five groups consisting of eight patients each) to either intervention group (low venous reservoir volume, 200-300 mL) or control group (venous reservoir volume > 300 mL).

Primary endpoint is to investigate if the amount of air emboli passing through the oxygenator to the arterial line differs between bicaval and cavoatrial venous cannulation during extracorporeal circulation. Secondary endpoints are the relative difference in amount air emboli between the groups, if there is any correlation between the amount of air in venous line and the amount of air passing through the oxygenator to the arterial line during extracorporeal circulation, and if difference is seen on the amount of air passing through the oxygenator depending on the level of volume in the venous reservoir.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 28, 2023
• Est. primary completion date: August 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients > 18 years

• Elective bicaval cannulation (mitral valve repair/replacement (MVR) or MVR + coronary artery bypass grafting (CABG))

• Elective cavoatrial cannulation (aortic valve repair/replacement (AVR) or AVR + CABG

• Planned normothermia (35-37°C)

Exclusion Criteria:

• Acute heart surgery

• Adult Congenital Heart Disease (ACHD) surgery

• Endocarditis

• Reoperation (primary procedure > 2 years ago)

• Perioperative iatrogenic adverse events (major bleeding, aortic dissection, other severe complications)

Related Conditions & MeSH terms

• Air Embolism
• Embolism
• Embolism, Air
• Extracorporeal Circulation; Complications

Intervention

Diagnostic Test:
• Volume control
Volume control in venous reservoir during extracorporeal circulation.

Locations

Country	Name	City	State
Sweden	Department of Cardiothoracic Surgery, Perfusion. Sahlgrenska University Hospital.	Gothenburg	Vastra Gotaland Region

Sponsors (1)

Lead Sponsor	Collaborator
Petronella Torild

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in count (number) of air emboli passing through the oxygenator to the arterial line between bicaval and cavoatrial venous cannulation.	Bubble counter measurements	1 day (During extracorporeal circulation)
Primary	Difference in volume (nano liter) of air emboli passing through the oxygenator to the arterial line between bicaval and cavoatrial venous cannulation.	Bubble counter measurements	1 day (During extracorporeal circulation)
Secondary	Difference in the amount of air emboli in venous tubing between bicaval and cavoatrial cannulation.	Bubble counter measurements	1 day (During extracorporeal circulation)
Secondary	Correlation between the amount of air in venous line and the amount of air passing through the oxygenator to the arterial line during extracorporeal circulation.	Bubble counter measurements	1 day (During extracorporeal circulation)
Secondary	Difference in amount of air passing through the oxygenator depending on the volume in the venous reservoir (200-300 mL versus > 300 mL).	Bubble counter measurements	1 day (During extracorporeal circulation)