Clinical trial NCT05820828: Comparing Air Embolic Load in Two Venous Cannulation Methods, 40 Patients Undergoing Elective Valve Surgery.
Official title: Does Venous Cannulation Method Affect Air Embolic Load to the Patient During Extracorporeal Circulation?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extracorporeal Circulation; Complications
Air Embolism
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Difference in count (number) of air emboli passing through the oxygenator to the arterial line between bicaval and cavoatrial venous cannulation.
timeFrame: 1 day (During extracorporeal circulation)
measure: Difference in volume (nano liter) of air emboli passing through the oxygenator to the arterial line between bicaval and cavoatrial venous cannulation.
timeFrame: 1 day (During extracorporeal circulation)
Secondary outcomes:
measure: Difference in the amount of air emboli in venous tubing between bicaval and cavoatrial cannulation.
timeFrame: 1 day (During extracorporeal circulation)
measure: 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.
timeFrame: 1 day (During extracorporeal circulation)
measure: Difference in amount of air passing through the oxygenator depending on the volume in the venous reservoir (200-300 mL versus > 300 mL).
timeFrame: 1 day (During extracorporeal circulation)
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Department of Cardiothoracic Surgery, Perfusion. Sahlgrenska University Hospital.
state: Vastra Gotaland Region
Study officials:
affiliation: Dep of Anesthesiology and Intensive Care Medicine, Sahlgrenska University Hospital
name: Tor Damen, PhD
role: PRINCIPAL_INVESTIGATOR
References: