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

NCT05820828 | Completed

• 1 other identifier: 2023-00204-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Extracorporeal Circulation; Complications; Air Embolism

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Difference in the amount of air emboli in venous tubing between bicaval and cavoatrial cannulation.

  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.

  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).

  1 day (During extracorporeal circulation)

Study Arms (2)

Control group

NO INTERVENTION

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).

Interventional group

EXPERIMENTAL

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

Interventions

Volume control DIAGNOSTIC_TEST

Volume control in venous reservoir during extracorporeal circulation.

Interventional group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Petronella Torild: lead

Study Sites (1)

Department of Cardiothoracic Surgery, Perfusion. Sahlgrenska University Hospital.

Gothenburg, Västra Götaland County, 41345, Sweden

Location

Related Publications (1)

• Torild P, Corderfeldt Keiller A, Damen T. Does the venous cannulation method affect gaseous embolic load to the patient during extracorporeal circulation? Perfusion. 2026 Jan;41(1):102-109. doi: 10.1177/02676591251344859. Epub 2025 May 20.

  PMID: 40393695 DERIVED

MeSH Terms

Conditions

Embolism, Air

Condition Hierarchy (Ancestors)

Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tor Damen, PhD

  Dep of Anesthesiology and Intensive Care Medicine, Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Perfusionist aspirant

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 20, 2023
• Study Start: April 21, 2023
• Primary Completion: August 28, 2023
• Study Completion: August 28, 2023
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)