Carbon DioxideCAR-DRIVERNCT04548687
a Randomized Clinical Trial Evaluating the Effectiveness of Carbon Dioxide Use in Cardiac Surgery
A study testing carbon dioxide insufflation and No carbon dioxide insufflation in people with Carbon Dioxide, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
study of the efficacy and safety of carbon dioxide in cardiac surgery: repeated or minimally invasive Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carbon Dioxide
- What is being tested?
- carbon dioxide insufflation and No carbon dioxide insufflation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- 19 Jun 2020to 20 Jun 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned cardiac surgery on the left heart with limited deaeration: Minimally invasive approach (mininotomy, minimally invasive lateral thoracotomy); Re-intervention
- Signed informed voluntary consent
Who cannot join
- Patient refusal to participate in any stage of the study
- History of stroke, transient ischemic attack
- Hemodynamically significant stenosis of the brachiocephalic arteries (more than 70%)
- Swelling or thrombosis of the heart
- LV dysfunction (EF less than 30%)
- Atherosclerosis of the aorta (atheromatosis)
- Surgical access conversion
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
"E.Meshalkin National medical research center" of the Ministry of Health of the Russian Federation
Novosibirsk
Alexander V. Bogachev-Prokophiev, MD, PhD, +73833476029, bogachev.prokophiev@gmail.com
Sergei A. Budagaev, +73833476029, ser.bud.med@gmail.com
About this study
Official title: Pilot Prospective Randomized Clinical Trial "Insufflation of Carbon Dioxide During Minimally Invasive and Repeated Cardiac Surgery"
study of the efficacy and safety of carbon dioxide in cardiac surgery: repeated or minimally invasive
Read the detailed description
prospective randomized clinical single-center study of the efficacy and safety of using carbon dioxide in deaeration of cardiac cavities during cardiac surgery (repeated interventions and minimally invasive interventions)
- Conditions
- Carbon Dioxide
- Being tested
- carbon dioxide insufflation, No carbon dioxide insufflation
- Keywords
- carbon dioxide, cardiac surgery, delirium, minimally invasive intervention, redo cardiac surgery
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbon dioxide insufflationProcedure or surgery
Also called carbon dioxide
Carbon dioxide insufflation at a rate of 5 l / min. through the Redon drainage during cardiac surgery (minimally invasive or repeated) during cardiopulmonary bypass
No carbon dioxide insufflationProcedure or surgery
Also called standard methods of deaeration
standard methods of deaeration of cardiac cavities: manual method, change in body position, through the cannula of the ascending aorta, through the drainage of the left ventricle
| Study group | Role | What they receive |
|---|---|---|
| carbon dioxide insufflation | Active comparator | patients with planned minimally invasive or repeated cardiac surgery using standard methods of deaeration of cardiac cavities, supplemented with carbon dioxide insufflation during surgery + standard methods of deaeration of cardiac cavities Receives: Procedure: carbon dioxide insufflation |
| no carbon dioxide | Other | standard methods of deaeration of cardiac cavities: manual method, change in body position, through the cannula of the ascending aorta, through the drainage of the left ventricle Receives: Procedure: No carbon dioxide insufflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
delirium: CAM-ICU, 3-D CAM
positive test development of postoperative delirium: Richmond Agitation-Sedation Scale, Confusion Assessment Method-Intensive Care Unit (more than one error) - while in the intensive care unit; positive test the 3-Minute Diagnostic Interview for Confusion Assessment Method (CAM) defined delirium - while in the ward of the department: The CAM algorithm is considered positive if the following features are present: Feature 1) Acute onset or fluctuating course and Feature 2) Inattention and either Feature 3) Disorganized thinking or Feature 4) Altered level of consciousness.
Measured: 7 days after surgery
Secondary outcomes (2)
deaeration time
deaeration time according to transesophageal echocardiography data
Measured: intraoperatively
neurocognitive dysfunction
development of neurocognitive dysfunction: Montreal Cognitive Assessment - two days before surgery and 7 days after surgery
Measured: 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start19 Jun 2020
- Primary completion20 Jun 2021 (estimated)
- Study completion20 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbon DioxideStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: patients with planned minimally invasive or repeated cardiac surgery using standard methods of deaeration of cardiac cavities. Group 2: patients with planned minimally invasive or repeated cardiac surgery using standard methods of deaeration of cardiac cavities, supplemented with carbon dioxide insufflation during surgery
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Alexander V. Bogachev-Prokophiev, MD, PhD, Principal investigator, E.Meshalkin National medical research center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548687
- Sponsor's protocol ID
- 496
- Acronym
- CAR-DRIVER
- Status last verified
- Jun 2020
- First submitted
- 1 Sep 2020
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Prospective Randomized Clinical Trial "Insufflation of Carbon Dioxide During Minimally Invasive and Repeated Cardiac Surgery"
- ClinicalTrials.gov ID
- NCT04548687
- Acronym / sponsor ID
- CAR-DRIVER / 496
- Conditions
- Carbon Dioxide
- Keywords
- carbon dioxide, cardiac surgery, delirium, minimally invasive intervention, redo cardiac surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 20 Jun 2021 (estimated)
- Study completion
- 20 Jun 2022 (estimated)
- First posted
- 14 Sep 2020 (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.
study of the efficacy and safety of carbon dioxide in cardiac surgery: repeated or minimally invasive
Detailed description
prospective randomized clinical single-center study of the efficacy and safety of using carbon dioxide in deaeration of cardiac cavities during cardiac surgery (repeated interventions and minimally invasive interventions)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group 1: patients with planned minimally invasive or repeated cardiac surgery using standard methods of deaeration of cardiac cavities. Group 2: patients with planned minimally invasive or repeated cardiac surgery using standard methods of deaeration of cardiac cavities, supplemented with carbon dioxide insufflation during surgery
| Arm | Type | Receives |
|---|---|---|
| carbon dioxide insufflation | Active comparator | Procedure: carbon dioxide insufflationpatients with planned minimally invasive or repeated cardiac surgery using standard methods of deaeration of cardiac cavities, supplemented with carbon dioxide insufflation during surgery + standard methods of deaeration of cardiac cavities |
| no carbon dioxide | Other | Procedure: No carbon dioxide insufflationstandard methods of deaeration of cardiac cavities: manual method, change in body position, through the cannula of the ascending aorta, through the drainage of the left ventricle |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Planned cardiac surgery on the left heart with limited deaeration: Minimally invasive approach (mininotomy, minimally invasive lateral thoracotomy); Re-intervention
- Signed informed voluntary consent
Key exclusion criteria (7 listed)
- Patient refusal to participate in any stage of the study
- History of stroke, transient ischemic attack
- Hemodynamically significant stenosis of the brachiocephalic arteries (more than 70%)
- Swelling or thrombosis of the heart
- LV dysfunction (EF less than 30%)
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 |
|---|---|---|
| carbon dioxide insufflationAlso: carbon dioxideCarbon dioxide insufflation at a rate of 5 l / min. through the Redon drainage during cardiac surgery (minimally invasive or repeated) during cardiopulmonary bypass | Procedure or surgery | carbon dioxide insufflation |
| No carbon dioxide insufflationAlso: standard methods of deaerationstandard methods of deaeration of cardiac cavities: manual method, change in body position, through the cannula of the ascending aorta, through the drainage of the left ventricle | Procedure or surgery | no carbon dioxide |
Primary outcome
delirium: CAM-ICU, 3-D CAM
Time frame: 7 days after surgery
positive test development of postoperative delirium: Richmond Agitation-Sedation Scale, Confusion Assessment Method-Intensive Care Unit (more than one error) - while in the intensive care unit; positive test the 3-Minute Diagnostic Interview for Confusion Assessment Method (CAM) defined delirium - while in the ward of the department: The CAM algorithm is considered positive if the following features are present: Feature 1) Acute onset or fluctuating course and Feature 2) Inattention and either Feature 3) Disorganized thinking or Feature 4) Altered level of consciousness.
2 secondary outcomes
deaeration time
Time frame: intraoperatively
neurocognitive dysfunction
Time frame: 7 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
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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.
Alexander V. Bogachev-Prokophiev, MD, PhD principal investigator
E.Meshalkin National medical research center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing carbon dioxide insufflation and No carbon dioxide insufflation in people with Carbon Dioxide, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
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 7 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 14 Sep 2020. 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 Russia. 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 Alexander V. Bogachev-Prokophiev, MD, PhD (+73833476029, bogachev.prokophiev@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
delirium: CAM-ICU, 3-D CAM (time frame: 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2020.