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

Primary Purpose

Extracorporeal Circulation; Complications, Air Embolism

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Volume control
Sponsored by
Petronella Torild
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Extracorporeal Circulation; Complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Department of Cardiothoracic Surgery, Perfusion. Sahlgrenska University Hospital.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Interventional group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Difference in the amount of air emboli in venous tubing between bicaval and cavoatrial cannulation.
Bubble counter measurements
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.
Bubble counter measurements
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

Full Information

First Posted
March 16, 2023
Last Updated
May 19, 2023
Sponsor
Petronella Torild
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1. Study Identification

Unique Protocol Identification Number
NCT05820828
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2023 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Petronella Torild

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extracorporeal Circulation; Complications, Air Embolism

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
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).
Arm Title
Interventional group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Volume control
Intervention Description
Volume control in venous reservoir during extracorporeal circulation.
Primary Outcome Measure Information:
Title
Difference in count (number) of air emboli passing through the oxygenator to the arterial line between bicaval and cavoatrial venous cannulation.
Description
Bubble counter measurements
Time Frame
1 day (During extracorporeal circulation)
Title
Difference in volume (nano liter) of air emboli passing through the oxygenator to the arterial line between bicaval and cavoatrial venous cannulation.
Description
Bubble counter measurements
Time Frame
1 day (During extracorporeal circulation)
Secondary Outcome Measure Information:
Title
Difference in the amount of air emboli in venous tubing between bicaval and cavoatrial cannulation.
Description
Bubble counter measurements
Time Frame
1 day (During extracorporeal circulation)
Title
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.
Description
Bubble counter measurements
Time Frame
1 day (During extracorporeal circulation)
Title
Difference in amount of air passing through the oxygenator depending on the volume in the venous reservoir (200-300 mL versus > 300 mL).
Description
Bubble counter measurements
Time Frame
1 day (During extracorporeal circulation)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tor Damén, PhD
Phone
0046313427873
Email
tor.damen@vgregion.se
First Name & Middle Initial & Last Name or Official Title & Degree
Petronella AE Torild, Student
Phone
0046733546590
Email
petronella.torild@vgregion.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tor Damen, PhD
Organizational Affiliation
Dep of Anesthesiology and Intensive Care Medicine, Sahlgrenska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiothoracic Surgery, Perfusion. Sahlgrenska University Hospital.
City
Gothenburg
State/Province
Vastra Gotaland Region
ZIP/Postal Code
41345
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petronella AE Torild
Phone
0046313427268
Email
petronella.torild@vgregion.se

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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