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Completed

NCT Number: NCT05820828

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiothoracic Surgery, Perfusion. Sahlgrenska University Hospital.

Gothenburg, Västra Götaland County, 41345, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Volume control

Diagnostic Test

Volume control in venous reservoir during extracorporeal circulation.

Primary outcomes

  1. Difference in count (number) of air emboli passing through the oxygenator to the arterial line between bicaval and cavoatrial venous cannulation.

    Time frame: 1 day (During extracorporeal circulation)

    Bubble counter measurements

  2. Difference in volume (nano liter) of air emboli passing through the oxygenator to the arterial line between bicaval and cavoatrial venous cannulation.

    Time frame: 1 day (During extracorporeal circulation)

    Bubble counter measurements

Secondary outcomes

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

    Time frame: 1 day (During extracorporeal circulation)

    Bubble counter measurements

  2. 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.

    Time frame: 1 day (During extracorporeal circulation)

    Bubble counter measurements

  3. Difference in amount of air passing through the oxygenator depending on the volume in the venous reservoir (200-300 mL versus > 300 mL).

    Time frame: 1 day (During extracorporeal circulation)

    Bubble counter measurements

Sponsors and collaborators

Lead sponsor

Petronella Torild

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 20, 2023
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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