Embolism Air Post-ProceduralNCT03961425
CO2 Field Saturating Alternative Techniques Comparison
A study testing NO CO2, CO2 Cannula and CO2 Cardia in people with Embolism Air Post-Procedural, run by Cardiochirurgia E.H. at 1 site in Italy.
Trial summary
Prospective Randomized study comparing three strategy of deairing (NO CO2 insufflation, CO2 insufflation with non specific cannula, CO2 insufflation with commercial dedicated diffuser) as regarding Time to Complete Deairing measured from declamping via TEE Echo and Neurological Events at Wake Up Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Embolism Air Post-Procedural
- What is being tested?
- NO CO2, CO2 Cannula and CO2 Cardia
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2019to 15 Jul 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Isolated, Elective Aortic Valve Replacement or combined AVR and CABG
- -
Who cannot join
- any other kind of operation
- Urgency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardia Carbonaid VS Standard Cannula VS NO CO2 Approach: Impact on Time to Complete Deairing and Clinical Neurological Events; a Randomized Prospective Study.
Prospective Randomized study comparing three strategy of deairing (NO CO2 insufflation, CO2 insufflation with non specific cannula, CO2 insufflation with commercial dedicated diffuser) as regarding Time to Complete Deairing measured from declamping via TEE Echo and Neurological Events at Wake Up
Read the detailed description
The impact of air bubbles into the cerebral circulation after open heart surgery has been a topic of discussion since the introduction of the heart-lung machine, and flooding the surgical field with CO2, which is heavier than Azote and Oxygen but over ten times more soluble seems a promising technique to minimize the presence of air microemboli. However very few studies have been conducted to ascertain what is the most efficient way to administer this treatment, or even of this treatment really impacts deairing time and clinical neurological events.
This study aims at comparing the use of CO2 (administered in two different ways: a simple cannula, which might be prone to emulsioning air and CO2 not reaching a complete CO2 saturation and a specific commercial diffuser which states promises complete filed saturation) to the no-CO2 standard approach.
The primary end point will be Time to Complete deairing as measured by intraoperative transesophageal echo while the secondary end point will be the incidence of clinical neurological events the day after the operation.
- Conditions
- Embolism Air Post-Procedural
- Being tested
- NO CO2, CO2 Cannula, CO2 Cardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NO CO2Behavioural
Traditional mechanical Deairing
CO2 CannulaDevice
Also called NON specific, low cost delivery system
NON specific, low cost delivery system
CO2 CardiaDevice
Also called Specific Commercial CO2 Diffuser
Specific Commercial CO2 Diffuser
| Study group | Role | What they receive |
|---|---|---|
| NO CO2 | Active comparator | Traditional De Airing maneuver Receives: Behavioral: NO CO2 |
| CO2 Cannula | Active comparator | CO2 at 8 l/min since 2 minutes before aortic cross clamp delivered by non specific needle cannula Receives: Device: CO2 Cannula |
| CO2 Cardia | Active comparator | CO2 at 8 l/min since 2 minutes before aortic cross clamp delivered by commercial diffuser Cardia Receives: Device: CO2 Cardia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Complete Deairing
Number of seconds since Declamping until no more air bubbles are visible on TEE Echo
Measured: Intraoperative
Secondary outcomes (1)
Neurological Events at Wake Up
Either Convulsions, Transitory Ischemic Attack or Full Stroke
Measured: The day after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start1 Jun 2019
- Primary completion1 Jul 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Embolism Air Post-ProceduralStudies 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
- Factorial
- Model description
- Random allocation in 1:1:1 to either NO CO2, CO2 with non specific cannula, CO2 with dedicated diffuser
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiochirurgia E.H.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Weltert, Cardiochirurgia E.H.
- Investigators
- Luca Weltert, MD, Principal investigator, European Hospital HEart Surgeon - Unicamillus Professor of Biostatistics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03961425
- Sponsor's protocol ID
- 2019-01
- Status last verified
- Jul 2021
- First submitted
- 22 May 2019
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nyman J, Svenarud P, van der Linden J. Carbon dioxide de-airing in minimal invasive cardiac surgery, a new effective device. J Cardiothorac Surg. 2019 Jan 17;14(1):12. doi: 10.1186/s13019-018-0824-4.
PubMed 30654802Listewnik M, Kotfis K, Slozowski P, Mokrzycki K, Brykczynski M. The influence of carbon dioxide field flooding in mitral valve operations with cardiopulmonary bypass on S100ss level in blood plasma in the aging brain. Clin Interv Aging. 2018 Sep 25;13:1837-1845. doi: 10.2147/CIA.S177356. eCollection 2018.
PubMed 30288036Benedetto U, Caputo M, Guida G, Bucciarelli-Ducci C, Thai J, Bryan A, Angelini GD. Carbon Dioxide Insufflation During Cardiac Surgery: A Meta-analysis of Randomized Controlled Trials. Semin Thorac Cardiovasc Surg. 2017 Autumn;29(3):301-310. doi: 10.1053/j.semtcvs.2017.05.002. Epub 2017 May 23.
PubMed 29195572Ganguly G, Dixit V, Patrikar S, Venkatraman R, Gorthi SP, Tiwari N. Carbon dioxide insufflation and neurocognitive outcome of open heart surgery. Asian Cardiovasc Thorac Ann. 2015 Sep;23(7):774-80. doi: 10.1177/0218492315583562. Epub 2015 May 4.
PubMed 25939908Chatterjee S, Greenberg SB, Brown J, Murphy GS, Pearson PJ, Alexander JC. Simple technique to verify CO(2) diffusion with the CarbonAid device. Heart Surg Forum. 2012 Aug;15(4):E212-4. doi: 10.1532/HSF98.20121015.
PubMed 22917826Chaudhuri K, Storey E, Lee GA, Bailey M, Chan J, Rosenfeldt FL, Pick A, Negri J, Gooi J, Zimmet A, Esmore D, Merry C, Rowland M, Lin E, Marasco SF. Carbon dioxide insufflation in open-chamber cardiac surgery: a double-blind, randomized clinical trial of neurocognitive effects. J Thorac Cardiovasc Surg. 2012 Sep;144(3):646-653.e1. doi: 10.1016/j.jtcvs.2012.04.010. Epub 2012 May 12.
PubMed 22578685Al-Rashidi F, Landenhed M, Blomquist S, Hoglund P, Karlsson PA, Pierre L, Koul B. Comparison of the effectiveness and safety of a new de-airing technique with a standardized carbon dioxide insufflation technique in open left heart surgery: a randomized clinical trial. J Thorac Cardiovasc Surg. 2011 May;141(5):1128-33. doi: 10.1016/j.jtcvs.2010.07.013. Epub 2010 Sep 3.
PubMed 20817209Martens S, Neumann K, Sodemann C, Deschka H, Wimmer-Greinecker G, Moritz A. Carbon dioxide field flooding reduces neurologic impairment after open heart surgery. Ann Thorac Surg. 2008 Feb;85(2):543-7. doi: 10.1016/j.athoracsur.2007.08.047.
PubMed 18222261
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardia Carbonaid VS Standard Cannula VS NO CO2 Approach: Impact on Time to Complete Deairing and Clinical Neurological Events; a Randomized Prospective Study.
- ClinicalTrials.gov ID
- NCT03961425
- Acronym / sponsor ID
- 2019-01
- Conditions
- Embolism Air Post-Procedural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Cardiochirurgia E.H.University, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 23 May 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.
Prospective Randomized study comparing three strategy of deairing (NO CO2 insufflation, CO2 insufflation with non specific cannula, CO2 insufflation with commercial dedicated diffuser) as regarding Time to Complete Deairing measured from declamping via TEE Echo and Neurological Events at Wake Up
Detailed description
The impact of air bubbles into the cerebral circulation after open heart surgery has been a topic of discussion since the introduction of the heart-lung machine, and flooding the surgical field with CO2, which is heavier than Azote and Oxygen but over ten times more soluble seems a promising technique to minimize the presence of air microemboli. However very few studies have been conducted to ascertain what is the most efficient way to administer this treatment, or even of this treatment really impacts deairing time and clinical neurological events.
This study aims at comparing the use of CO2 (administered in two different ways: a simple cannula, which might be prone to emulsioning air and CO2 not reaching a complete CO2 saturation and a specific commercial diffuser which states promises complete filed saturation) to the no-CO2 standard approach.
The primary end point will be Time to Complete deairing as measured by intraoperative transesophageal echo while the secondary end point will be the incidence of clinical neurological events the day after the operation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Random allocation in 1:1:1 to either NO CO2, CO2 with non specific cannula, CO2 with dedicated diffuser
| Arm | Type | Receives |
|---|---|---|
| NO CO2 | Active comparator | Behavioral: NO CO2Traditional De Airing maneuver |
| CO2 Cannula | Active comparator | Device: CO2 CannulaCO2 at 8 l/min since 2 minutes before aortic cross clamp delivered by non specific needle cannula |
| CO2 Cardia | Active comparator | Device: CO2 CardiaCO2 at 8 l/min since 2 minutes before aortic cross clamp delivered by commercial diffuser Cardia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Isolated, Elective Aortic Valve Replacement or combined AVR and CABG
- -
Key exclusion criteria (2 listed)
- any other kind of operation
- Urgency
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 |
|---|---|---|
| NO CO2Traditional mechanical Deairing | Behavioural | NO CO2 |
| CO2 CannulaAlso: NON specific, low cost delivery systemNON specific, low cost delivery system | Device | CO2 Cannula |
| CO2 CardiaAlso: Specific Commercial CO2 DiffuserSpecific Commercial CO2 Diffuser | Device | CO2 Cardia |
Primary outcome
Time to Complete Deairing
Time frame: Intraoperative
Number of seconds since Declamping until no more air bubbles are visible on TEE Echo
1 secondary outcome
Neurological Events at Wake Up
Time frame: The day after operation
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 27 Jul 2021.
- Background: PubMed 30654802Nyman J, Svenarud P, van der Linden J. Carbon dioxide de-airing in minimal invasive cardiac surgery, a new effective device. J Cardiothorac Surg. 2019 Jan 17;14(1):12. doi: 10.1186/s13019-018-0824-4.
- Background: PubMed 30288036Listewnik M, Kotfis K, Slozowski P, Mokrzycki K, Brykczynski M. The influence of carbon dioxide field flooding in mitral valve operations with cardiopulmonary bypass on S100ss level in blood plasma in the aging brain. Clin Interv Aging. 2018 Sep 25;13:1837-1845. doi: 10.2147/CIA.S177356. eCollection 2018.
- Background: PubMed 29195572Benedetto U, Caputo M, Guida G, Bucciarelli-Ducci C, Thai J, Bryan A, Angelini GD. Carbon Dioxide Insufflation During Cardiac Surgery: A Meta-analysis of Randomized Controlled Trials. Semin Thorac Cardiovasc Surg. 2017 Autumn;29(3):301-310. doi: 10.1053/j.semtcvs.2017.05.002. Epub 2017 May 23.
- Background: PubMed 25939908Ganguly G, Dixit V, Patrikar S, Venkatraman R, Gorthi SP, Tiwari N. Carbon dioxide insufflation and neurocognitive outcome of open heart surgery. Asian Cardiovasc Thorac Ann. 2015 Sep;23(7):774-80. doi: 10.1177/0218492315583562. Epub 2015 May 4.
- Background: PubMed 22917826Chatterjee S, Greenberg SB, Brown J, Murphy GS, Pearson PJ, Alexander JC. Simple technique to verify CO(2) diffusion with the CarbonAid device. Heart Surg Forum. 2012 Aug;15(4):E212-4. doi: 10.1532/HSF98.20121015.
- Background: PubMed 22578685Chaudhuri K, Storey E, Lee GA, Bailey M, Chan J, Rosenfeldt FL, Pick A, Negri J, Gooi J, Zimmet A, Esmore D, Merry C, Rowland M, Lin E, Marasco SF. Carbon dioxide insufflation in open-chamber cardiac surgery: a double-blind, randomized clinical trial of neurocognitive effects. J Thorac Cardiovasc Surg. 2012 Sep;144(3):646-653.e1. doi: 10.1016/j.jtcvs.2012.04.010. Epub 2012 May 12.
- Background: PubMed 20817209Al-Rashidi F, Landenhed M, Blomquist S, Hoglund P, Karlsson PA, Pierre L, Koul B. Comparison of the effectiveness and safety of a new de-airing technique with a standardized carbon dioxide insufflation technique in open left heart surgery: a randomized clinical trial. J Thorac Cardiovasc Surg. 2011 May;141(5):1128-33. doi: 10.1016/j.jtcvs.2010.07.013. Epub 2010 Sep 3.
- Background: PubMed 18222261Martens S, Neumann K, Sodemann C, Deschka H, Wimmer-Greinecker G, Moritz A. Carbon dioxide field flooding reduces neurologic impairment after open heart surgery. Ann Thorac Surg. 2008 Feb;85(2):543-7. doi: 10.1016/j.athoracsur.2007.08.047.
- Individual participant dataSharing planned: No
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.
Luca Weltert, MD principal investigator
European Hospital HEart Surgeon - Unicamillus Professor of Biostatistics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NO CO2, CO2 Cannula and CO2 Cardia in people with Embolism Air Post-Procedural, run by Cardiochirurgia E.H. at 1 site in Italy.
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 2 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 27 Jul 2021. 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 Italy. 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?
Time to Complete Deairing (time frame: Intraoperative). 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 NCT03961425, which also lists 8 linked publications.
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 27 Jul 2021.