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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volume control | Diagnostic Test | Volume control in venous reservoir during extracorporeal circulation. |
|
| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tor Damen, PhD | Dep of Anesthesiology and Intensive Care Medicine, Sahlgrenska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiothoracic Surgery, Perfusion. Sahlgrenska University Hospital. | Gothenburg | Västra Götaland County | 41345 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40393695 | Derived | 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. |
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| ID | Term |
|---|---|
| D004618 | Embolism, Air |
| ID | Term |
|---|---|
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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) |