Extracorporeal Circulation; ComplicationsNCT05820828
Comparing Air Embolic Load in Two Venous Cannulation Methods, 40 Patients Undergoing Elective Valve Surgery.
A study of Extracorporeal Circulation; Complications and Air Embolism, run by Petronella Torild at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Circulation; Complications, Air Embolism
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 21 Apr 2023to 28 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Cardiothoracic Surgery, Perfusion. Sahlgrenska University Hospital.
Gothenburg, Västra Götaland County, 41345
About this study
Official title: Does Venous Cannulation Method Affect Air Embolic Load to the Patient During Extracorporeal Circulation?
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.
- Being tested
- Volume control
- Medical subject headings
- Embolism, Air
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volume controlDiagnostic test
Volume control in venous reservoir during extracorporeal circulation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Volume control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in count (number) of air emboli passing through the oxygenator to the arterial line between bicaval and cavoatrial venous cannulation.
Bubble counter measurements
Measured: 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
Measured: 1 day (During extracorporeal circulation)
Secondary outcomes (3)
Difference in the amount of air emboli in venous tubing between bicaval and cavoatrial cannulation.
Bubble counter measurements
Measured: 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.
Bubble counter measurements
Measured: 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
Measured: 1 day (During extracorporeal circulation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start21 Apr 2023
- Primary completion28 Aug 2023
- Study completion28 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extracorporeal Circulation; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Petronella Torild
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Petronella Torild, Sahlgrenska University Hospital
- Investigators
- Tor Damen, PhD, Principal investigator, Dep of Anesthesiology and Intensive Care Medicine, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820828
- Sponsor's protocol ID
- 2023-00204-01
- Other IDs
- 2023
- Status last verified
- Apr 2024
- First submitted
- 16 Mar 2023
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40393695
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Venous Cannulation Method Affect Air Embolic Load to the Patient During Extracorporeal Circulation?
- ClinicalTrials.gov ID
- NCT05820828
- Acronym / sponsor ID
- 2023-00204-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Petronella TorildUniversity, hospital or other
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 28 Aug 2023 (actual)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Diagnostic Test: Volume controlPatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volume controlVolume control in venous reservoir during extracorporeal circulation. | Diagnostic test | Interventional group |
Primary outcome
Difference in count (number) of air emboli passing through the oxygenator to the arterial line between bicaval and cavoatrial venous cannulation.
Time frame: 1 day (During extracorporeal circulation)
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.
Time frame: 1 day (During extracorporeal circulation)
Bubble counter measurements
3 secondary outcomes
Difference in the amount of air emboli in venous tubing between bicaval and cavoatrial cannulation.
Time frame: 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.
Time frame: 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).
Time frame: 1 day (During extracorporeal circulation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Derived from this study: PubMed 40393695Torild 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tor Damen, PhD principal investigator
Dep of Anesthesiology and Intensive Care Medicine, Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Extracorporeal Circulation; Complications and Air Embolism, run by Petronella Torild at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in count (number) of air emboli passing through the oxygenator to the arterial line between bicaval and cavoatrial venous cannulation. (time frame: 1 day (During extracorporeal circulation)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05820828, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.