Adult Patients Undergoing Open Heart Replacement of the Aortic Valve for Aortic Stenosis or InsufficiencyNCT04202575
Elimination of CO2-insufflation-induced Hypercarbia in Open Heart Surgery
A study testing Tube clamping in people with Adult Patients Undergoing Open Heart Replacement of the Aortic Valve for Aortic Stenosis or Insufficiency, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
The study aim was to evaluate if an additional separate venous reservoir eliminates CO2-insufflation induced hypercapnia and keeps sweep gas flow of the oxygenator constant during open heart surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Patients Undergoing Open Heart Replacement of the Aortic Valve for Aortic Stenosis or Insufficiency
- What is being tested?
- Tube clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2019to Jan 2020
- 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
- adult patients undergoing open heart replacement of the aortic valve
- Use of perioperative cardiopulmonary bypass
Who cannot join
- Denied participation in the study
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm
Jan van der Linden, MD, PhD, jan.vanderlinden@ki.se
About this study
Official title: Elimination of CO2-insufflation-induced Hypercarbia in Open Heart Surgery Using a Separate Reservoir for Suction of Blood From the Open Surgical Wound
The study aim was to evaluate if an additional separate venous reservoir eliminates CO2-insufflation induced hypercapnia and keeps sweep gas flow of the oxygenator constant during open heart surgery.
Read the detailed description
Background: CO2-gas insufflation is used for continuous de-airing during open heart surgery. The study aim was to evaluate if an additional separate venous reservoir eliminates CO2-insufflation induced hypercapnea and keeps sweep gas flow of the oxygenator constant.
Methods: A separate small reservoir are used during CPB in addition to a standard large venous reservoir. The small reservoir receive drained wound blood and CO2-gas continuously via a suction drain (1 L/min) and handheld suction devices from the open surgical wound. CO2-gas is insufflated via a gas-diffuser in the open surgical wound at 10 L/min. During cross-clamping, gas and blood are either continuously drained to the standard large venous reservoir or not, every 5 minutes after steady state of PaCO2 is observed, after adjustment of sweep gas flow as necessary. Mean values for each setup (2-4 times) for each patient will be analyzed with Wilcoxon rank-sum test.
- Being tested
- Tube clamping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tube clampingProcedure or surgery
Clamping of the tube between the additional and standard venous reservoir
| Study group | Role | What they receive |
|---|---|---|
| conventional setup | No intervention | Blood and gas from the coronary and cardiotomy suction devices is continuously evacuated via the additional reservoir to the standard reservoir. |
| Intervention setup | Experimental | The connecting tube between the additional and standard venous reservoir is clamped. Thus, blood and gas from the coronary and cardiotomy suction devices are collected in the additional venous reservoir. During the intervention setup, the blood in the additional venous reservoir is only evacuated to the standard reservoir if the volume exceeded 800ml, and always with a remaining volume of 100 mL blood to keep the CO2-gas trapped in the additional venous reservoir. Receives: Procedure: Tube clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in PaCO2 (kPa)
Measured: At 5 minutes steady state
Secondary outcomes (1)
Oxygenator sweep gas flow rate (L/min)
Measured: At 5 minutes steady state
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start1 Aug 2019
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
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 Adult Patients Undergoing Open Heart Replacement of the Aortic Valve for Aortic Stenosis or InsufficiencyStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan van der Linden, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202575
- Sponsor's protocol ID
- 2018/1091-31
- Status last verified
- Dec 2019
- First submitted
- 15 Dec 2019
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If other researchers would show interest in the data, we may considered providing data on a group level. However, individual data cannot be made available due to the rules in the GDPR.
Publications
Nyman J, Holm M, Fux T, Sesartic V, Fredby M, Svenarud P, van der Linden J. Elimination of CO2 insufflation-induced hypercapnia in open heart surgery using an additional venous reservoir. Interact Cardiovasc Thorac Surg. 2021 Aug 18;33(3):483-488. doi: 10.1093/icvts/ivab082.
PubMed 34363470
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elimination of CO2-insufflation-induced Hypercarbia in Open Heart Surgery Using a Separate Reservoir for Suction of Blood From the Open Surgical Wound
- ClinicalTrials.gov ID
- NCT04202575
- Acronym / sponsor ID
- 2018/1091-31
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 17 Dec 2019 (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 study aim was to evaluate if an additional separate venous reservoir eliminates CO2-insufflation induced hypercapnia and keeps sweep gas flow of the oxygenator constant during open heart surgery.
Detailed description
Background: CO2-gas insufflation is used for continuous de-airing during open heart surgery. The study aim was to evaluate if an additional separate venous reservoir eliminates CO2-insufflation induced hypercapnea and keeps sweep gas flow of the oxygenator constant.
Methods: A separate small reservoir are used during CPB in addition to a standard large venous reservoir. The small reservoir receive drained wound blood and CO2-gas continuously via a suction drain (1 L/min) and handheld suction devices from the open surgical wound. CO2-gas is insufflated via a gas-diffuser in the open surgical wound at 10 L/min. During cross-clamping, gas and blood are either continuously drained to the standard large venous reservoir or not, every 5 minutes after steady state of PaCO2 is observed, after adjustment of sweep gas flow as necessary. Mean values for each setup (2-4 times) for each patient will be analyzed with Wilcoxon rank-sum test.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional setup | No intervention | –Blood and gas from the coronary and cardiotomy suction devices is continuously evacuated via the additional reservoir to the standard reservoir. |
| Intervention setup | Experimental | Procedure: Tube clampingThe connecting tube between the additional and standard venous reservoir is clamped. Thus, blood and gas from the coronary and cardiotomy suction devices are collected in the additional venous reservoir. During the intervention setup, the blood in the additional venous reservoir is only evacuated to the standard reservoir if the volume exceeded 800ml, and always with a remaining volume of 100 mL blood to keep the CO2-gas trapped in the additional venous reservoir. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients undergoing open heart replacement of the aortic valve
- Use of perioperative cardiopulmonary bypass
Key exclusion criteria (1 listed)
- Denied participation in the study
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 |
|---|---|---|
| Tube clampingClamping of the tube between the additional and standard venous reservoir | Procedure or surgery | Intervention setup |
Primary outcome
Difference in PaCO2 (kPa)
Time frame: At 5 minutes steady state
1 secondary outcome
Oxygenator sweep gas flow rate (L/min)
Time frame: At 5 minutes steady state
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
- Derived from this study: PubMed 34363470Nyman J, Holm M, Fux T, Sesartic V, Fredby M, Svenarud P, van der Linden J. Elimination of CO2 insufflation-induced hypercapnia in open heart surgery using an additional venous reservoir. Interact Cardiovasc Thorac Surg. 2021 Aug 18;33(3):483-488. doi: 10.1093/icvts/ivab082.
- Individual participant dataSharing planned: No. If other researchers would show interest in the data, we may considered providing data on a group level. However, individual data cannot be made available due to the rules in the GDPR.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tube clamping in people with Adult Patients Undergoing Open Heart Replacement of the Aortic Valve for Aortic Stenosis or Insufficiency, run by Karolinska University Hospital 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Dec 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan van der Linden, MD, PhD (+468-51770121, jan.vanderlinden@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in PaCO2 (kPa) (time frame: At 5 minutes steady state). 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 NCT04202575, 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 19 Dec 2019.