NCT05820828

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

Completed NA Last updated 3 April 2024

What this trial tests

NA trial testing Volume control in Extracorporeal Circulation; Complications in 40 participants. Completed in 28 August 2023.

Timeline

21 April 2023

Primary endpoint
28 August 2023

28 August 2023

Quick facts

Lead sponsor	Petronella Torild
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	40
Start date	21 April 2023
Primary completion	28 August 2023
Estimated completion	28 August 2023
Sites	1 location across Sweden

Drugs / interventions tested

• Volume control

Conditions studied

• Extracorporeal Circulation; Complications — all drugs for Extracorporeal Circulation; Complications →
• Air Embolism — all drugs for Air Embolism →

Sponsor

Petronella Torild

Who can join

18 and older, any sex, with Extracorporeal Circulation; Complications or Air Embolism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Does the venous cannulation method affect gaseous embolic load to the patient during extracorporeal circulation?
   Torild P, Corderfeldt Keiller A, Damén T. · · 2026 · PMID 40393695 · DOI 10.1177/02676591251344859