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

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

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.

Study Overview

• Status: Completed
• Conditions: Extracorporeal Circulation; Complications; Air Embolism
• Intervention / Treatment: Diagnostic test: Volume control

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Vastra Gotaland Region
    • Gothenburg, Vastra Gotaland Region, Sweden, 41345
      • Department of Cardiothoracic Surgery, Perfusion. Sahlgrenska University Hospital.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Patient will during extracorporeal circulation be monitored and held in the range of > 300 mL in the venous reservoir. Patient will recieve fluid if needed to maintain correct level (crystalloids, colloids or erytrocytes depending on patients clinical status).
Experimental: Interventional group; Patient will during extracorporeal circulation be monitored and held in the range of 200 - 300 mL in the venous reservoir. To maintain correct level of volume, any excessive fluid will be drained into a sterile infusion bag during extracorporeal circulation. After the surgery, the patient will recieve the volume to ensure correct volume status.	Diagnostic test: Volume control; Volume control in venous reservoir during extracorporeal circulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in the amount of air emboli in venous tubing between bicaval and cavoatrial cannulation.	Bubble counter measurements	1 day (During extracorporeal circulation)
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)
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)

Collaborators and Investigators

• Sponsor: Petronella Torild
• Investigators: Principal Investigator: Tor Damen, PhD, Dep of Anesthesiology and Intensive Care Medicine, Sahlgrenska University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2023
• Primary Completion (Actual): August 28, 2023
• Study Completion (Actual): August 28, 2023

Study Registration Dates

• First Submitted: March 16, 2023
• First Submitted That Met QC Criteria: April 19, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Embolism; Embolism, Air
• Other Study ID Numbers: 2023-00204-01

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