Air EmbolismNCT02340741
Insufflation of Carbon Dioxide During Cardiac Surgery as Prevention Neurologic Complications
A study testing conventional prophylaxis of aeroembolism, conventional prophylaxis plus CO2 insufflation and cardiac surgery with opening of heart chambers in people with Air Embolism and Neurological Damage, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
Effect of intraoperative insufflation of carbon dioxide on the neurologic complications in the early postoperative period after open cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Air Embolism, Neurological Damage
- What is being tested?
- conventional prophylaxis of aeroembolism, conventional prophylaxis plus CO2 insufflation and cardiac surgery with opening of heart chambers
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 1 siteRussia
- Study dates
- Sep 2014to Sep 2017
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to sign Informed Consent and Release of Medical Information forms
- Age 18 - 70 years
- Patients scheduled on cardiac surgery with opening cavities
Who cannot join
- History of stroke and TIA
- Significant carotid artery stenosis
- Presence of initial severe encephalopathy
- Re-clamping of the aorta
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Novosibirsk State Research Institute of Circulation Pathology
Novosibirsk, Novosibirsk Territory, 630055
Alexander V Bogachev-Prokophiev, PhD, +79137539546, bogachev.prokophiev@gmail.com
Michael S Fomenko, +79612183098, enimol36@gmail.com
About this study
Official title: Assessing of Carbon Dioxide Insufflation on the Neurological Complications During Open Heart Operations
Effect of intraoperative insufflation of carbon dioxide on the neurologic complications in the early postoperative period after open cardiac surgery.
Read the detailed description
Arterial air embolism in cardiac surgery is not a rare complication, leading to neurological damage in the early postoperative period of 3-5%. Insufflation of carbon dioxide (CO2) into the operative field to prevent cerebral or myocardial damage by air embolism is reported since 1967 in open heart surgery (Selman MW et al. 1967).
Carbon dioxide fills the thoracic cavity by gravity and replaces air if adequately insufflated. Because solubility of CO2 is better than that of air, occlusion or flow disruption in arteries of the brain or the heart is thought to be diminished. Despite carefully performed deairing procedures as puncturing of the ascending aorta and cardiac massage, transcranial Doppler studies revealed large amounts of emboli during the first ejections of the beating heart (van der Linden J et al. 1991). In patiens with minimally invasive approach and redo valve surgery, deairing of the cardiac chambers has become more difficult.
Although the use of carbon dioxide when filling in the surgical field, as the prevention of air embolism reduces the number of intracardiac emboli according to transesophageal echocardiography there is no evidence of a sustained reduction in cerebrovascular events (G. Salvatore al. 2009).
- Conditions
- Air Embolism, Neurological Damage
- Being tested
- conventional prophylaxis of aeroembolism, conventional prophylaxis plus CO2 insufflation, cardiac surgery with opening of heart chambers
- Keywords
- carbon dioxide, postoperative cerebrovascular complications, air embolism
- Medical subject headings
- Embolism, Air, Trauma, Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional prophylaxis of aeroembolismProcedure or surgery
167 patients will be enrolled. Will perform standard way of aeroembolism prevention
conventional prophylaxis plus CO2 insufflationProcedure or surgery
167 patients will be enrolled. Will perform standard way of aeroembolism prevention and insufflation of carbon dioxide
cardiac surgery with opening of heart chambersProcedure or surgery
Patients with different clinical diagnoses, which is planned to cardiac surgery with the opening heart cavities
| Study group | Role | What they receive |
|---|---|---|
| conventional prophylaxis of aeroembolism | Other | Procedure: cardiac surgery with opening of heart chambers.
Will be including 167 patients to undergo cardiac surgery. After the main operation phase all heart cavities are sealed, left vent drainage is stopped, ascending aorta is punctured and cardiac massage is performed, ventilation is started and the heart is filled with volume. Operating table is positioned in the Trendelenburg position, and aorta is opened. The amount of air in the cavities is evaluated by transesophageal echocardiography. Receives: Procedure: conventional prophylaxis of aeroembolism; Procedure: cardiac surgery with opening of heart chambers |
| conventional prophylaxis plus CO2 insufflation | Other | Procedure: cardiac surgery with opening of heart chambers.
Will be including 167 patients to undergo cardiac surgery. After the main phase of the operation standard measures of aeroembolism prevention are carried out. The amount of air in the cavities is evaluated by transesophageal echocardiography. Receives: Procedure: conventional prophylaxis plus CO2 insufflation; Procedure: cardiac surgery with opening of heart chambers |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative neurological disorders (stroke, psychosis,encephalopathy), as measured by Confusion Assessment Method for the ICU, Richmond Agitation-Sedation Scale, Standardized Mini-Mental State Examination
conducting tests: Confusion Assessment Method for the ICU, Richmond Agitation-Sedation Scale, Standardized Mini-Mental State Examination
Measured: 14 days
Secondary outcomes (1)
hospital mortality
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startSep 2014
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Air EmbolismStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 334 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Aleksandr V Bogachev-Prokophiev, PhD, Principal investigator, Meshalkin Research Institute of Pathology of Circulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340741
- Sponsor's protocol ID
- 11-54-22
- Status last verified
- Mar 2016
- First submitted
- 16 Dec 2014
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing of Carbon Dioxide Insufflation on the Neurological Complications During Open Heart Operations
- ClinicalTrials.gov ID
- NCT02340741
- Acronym / sponsor ID
- 11-54-22
- Conditions
- Air Embolism, Neurological Damage
- Keywords
- carbon dioxide, postoperative cerebrovascular complications, air embolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 334 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Sep 2014
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 19 Jan 2015 (estimated)
- 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.
Effect of intraoperative insufflation of carbon dioxide on the neurologic complications in the early postoperative period after open cardiac surgery.
Detailed description
Arterial air embolism in cardiac surgery is not a rare complication, leading to neurological damage in the early postoperative period of 3-5%. Insufflation of carbon dioxide (CO2) into the operative field to prevent cerebral or myocardial damage by air embolism is reported since 1967 in open heart surgery (Selman MW et al. 1967).
Carbon dioxide fills the thoracic cavity by gravity and replaces air if adequately insufflated. Because solubility of CO2 is better than that of air, occlusion or flow disruption in arteries of the brain or the heart is thought to be diminished. Despite carefully performed deairing procedures as puncturing of the ascending aorta and cardiac massage, transcranial Doppler studies revealed large amounts of emboli during the first ejections of the beating heart (van der Linden J et al. 1991). In patiens with minimally invasive approach and redo valve surgery, deairing of the cardiac chambers has become more difficult.
Although the use of carbon dioxide when filling in the surgical field, as the prevention of air embolism reduces the number of intracardiac emboli according to transesophageal echocardiography there is no evidence of a sustained reduction in cerebrovascular events (G. Salvatore al. 2009).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional prophylaxis of aeroembolism | Other | Procedure: conventional prophylaxis of aeroembolism, Procedure: cardiac surgery with opening of heart chambersProcedure: cardiac surgery with opening of heart chambers. Will be including 167 patients to undergo cardiac surgery. After the main operation phase all heart cavities are sealed, left vent drainage is stopped, ascending aorta is punctured and cardiac massage is performed, ventilation is started and the heart is filled with volume. Operating table is positioned in the Trendelenburg position, and aorta is opened. The amount of air in the cavities is evaluated by transesophageal echocardiography. |
| conventional prophylaxis plus CO2 insufflation | Other | Procedure: conventional prophylaxis plus CO2 insufflation, Procedure: cardiac surgery with opening of heart chambersProcedure: cardiac surgery with opening of heart chambers. Will be including 167 patients to undergo cardiac surgery. After the main phase of the operation standard measures of aeroembolism prevention are carried out. The amount of air in the cavities is evaluated by transesophageal echocardiography. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to sign Informed Consent and Release of Medical Information forms
- Age 18 - 70 years
- Patients scheduled on cardiac surgery with opening cavities
Key exclusion criteria (5 listed)
- History of stroke and TIA
- Significant carotid artery stenosis
- Presence of initial severe encephalopathy
- Re-clamping of the aorta
- Emergency surgery
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 |
|---|---|---|
| conventional prophylaxis of aeroembolism167 patients will be enrolled. Will perform standard way of aeroembolism prevention | Procedure or surgery | conventional prophylaxis of aeroembolism |
| conventional prophylaxis plus CO2 insufflation167 patients will be enrolled. Will perform standard way of aeroembolism prevention and insufflation of carbon dioxide | Procedure or surgery | conventional prophylaxis plus CO2 insufflation |
| cardiac surgery with opening of heart chambersPatients with different clinical diagnoses, which is planned to cardiac surgery with the opening heart cavities | Procedure or surgery | conventional prophylaxis of aeroembolism, conventional prophylaxis plus CO2 insufflation |
Primary outcome
postoperative neurological disorders (stroke, psychosis,encephalopathy), as measured by Confusion Assessment Method for the ICU, Richmond Agitation-Sedation Scale, Standardized Mini-Mental State Examination
Time frame: 14 days
conducting tests: Confusion Assessment Method for the ICU, Richmond Agitation-Sedation Scale, Standardized Mini-Mental State Examination
1 secondary outcome
hospital mortality
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
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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.
Novosibirsk State Research Institute of Circulation Pathology
Novosibirsk, Russia
Aleksandr V Bogachev-Prokophiev, PhD principal investigator
Meshalkin Research Institute of Pathology of Circulation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional prophylaxis of aeroembolism, conventional prophylaxis plus CO2 insufflation and cardiac surgery with opening of heart chambers in people with Air Embolism and Neurological Damage, 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 3 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: status not confirmed, as of the sponsor's last update on 22 Mar 2016. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative neurological disorders (stroke, psychosis,encephalopathy), as measured by Confusion Assessment Method for the ICU, Richmond Agitation-Sedation Scale, Standardized Mini-Mental State Examination (time frame: 14 days). 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 22 Mar 2016.