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

• Sponsor: Petronella Torild (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05820828
• Collaborator: (none)
• Enrollment: 40
• Arms: 2
• Anticipated Duration (Months): 13.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Extracorporeal Circulation; Complications; Air Embolism	Diagnostic Test: Volume control	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Does Venous Cannulation Method Affect Air Embolic Load to the Patient During Extracorporeal Circulation?
• Anticipated Study Start Date: Apr 17, 2023
• Anticipated Primary Completion Date: Oct 31, 2023
• Anticipated Study Completion Date: May 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control group 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).
Experimental: Interventional group 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; Volume control in venous reservoir during extracorporeal circulation.

Outcome Measures

Primary Outcome Measures

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

   Bubble counter measurements

Secondary Outcome Measures

1. Difference in the amount of air emboli in venous tubing between bicaval and cavoatrial cannulation. [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. [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). [1 day (During extracorporeal circulation)]

   Bubble counter measurements

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Petronella Torild

Investigators

• Principal Investigator: Tor Damen, PhD, Dep of Anesthesiology and Intensive Care Medicine, Sahlgrenska University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Petronella Torild, Perfusionist aspirant, Sahlgrenska University Hospital, Sweden
• ClinicalTrials.gov Identifier: NCT05820828
• Other Study ID Numbers: 2023-00204-01
• First Posted: Apr 20, 2023
• Last Update Posted: Apr 20, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Embolism; Embolism, Air

Study Results

No Results Posted as of Apr 20, 2023