Aortic Valve DisorderNCT00934596
CO2 Versus Lund De-airing Technique in Heart Surgery
A study testing Lund de-airing technique and carbon-dioxide insufflation in people with Aortic Valve Disorder, run by Lund University.
Trial summary
To evaluate which of the two de-airing methods (CO2 insufflation vs. Lund de-airing technique) can shorten the left heart de-airing time and prevent or minimize cerebral air emboli during open surgery involving exposure of the left heart to the ambient air. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Aortic Valve Disorder
- What is being tested?
- Lund de-airing technique and carbon-dioxide insufflation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Oct 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients planned for aortic valve/root replacement or repair will be selected for the study
Who cannot join
- Patients with known
- chronic obstructive pulmonary disease,
- emphysema,
- previous thoracic or cardiac surgery,
- history of CVA or stroke and
- evidence of intraoperative pleural adhesions will be excluded from the study.
- Patients requiring internal mammary artery coronary bypass will also be excluded.
About this study
Official title: CO2 Insufflation vs Lund De-airing Technique For Open Left Heart Surgery - Safety and Efficacy
To evaluate which of the two de-airing methods (CO2 insufflation vs. Lund de-airing technique) can shorten the left heart de-airing time and prevent or minimize cerebral air emboli during open surgery involving exposure of the left heart to the ambient air.
To evaluate the cost effectiveness and possible side effects of CO2 de-airing technique compared to Lund de-airing technique.
Read the detailed description
Study design:
Prospective, randomized and controlled study involving 20 patients, 10 in each group. The de-airing time and the efficiency of the techniques will be assessed by trans-esophageal echocardiography (TEE) and trans-cranial echo-doppler monitoring (TCD). The cardiologists analyzing the TEE recordings will be blinded to the de-airing technique used (the recorded videos will be analyzed at the end of the study). The TCD monitoring will be done by on-line automatic recording of the micro embolic signals (MES) from the right and or left middle cerebral arteries and performed by single surgeon. The CO2 insufflation of the operating field will be performed according to manufacturer's guide lines. During entire study course one type of extracorporeal perfusion system will be used.The study will be registered in the international database. A prior approval will be sought from the hospital ethical committee for the study.
Patient selection:
Patients planned for aortic valve/root replacement or repair will be selected for the study
Exclusion criteria:
Patients with known: a) chronic obstructive pulmonary disease, b) emphysema, c) previous thoracic or cardiac surgery, d) history of CVA or stroke and e) evidence of intraoperative pleural adhesions will be excluded from the study. Patients requiring internal mammary artery coronary bypass will also be excluded.
Patient consent:
A written consent previously approved by the hospital ethical committee will be obtained from all patients before they are enrolled in the study (enclosure 3).
De-airing procedure:
Enrolled patients will be assigned randomly to one of the two following groups:
Control group ( newly developed de-airing technique in Lund ) :
In these patients (n=10) the pleura will be opened on both sides and the ventilator will be disconnected before aorta is cross-clamped and cardioplegia administered. At the end of the cardioplegic arrest, the aortic root and the LV will be actively vented and aortic cross clamp released. The time will be noted down (T1). The heart will be defibrillated to sinus or pacemaker induced rhythm. The heart will be kept empty by the LV vent and ejection avoided as monitored by continual intraoperative TEE and systemic arterial pressure tracing. At 35 Celsius body temperature, as measured from the thermistor in the urinary bladder, and with apparently good cardiac contraction the de-airing will begin. Inotropic drugs or systemic arterial vasodilators will be used as and when necessary to achieve good cardiac contraction. The time will be noted down (T2) (T2 - T1 = Pre ejection de-airing time). The LV preload will first now be successively increased by reducing the venous return from the heart-lung machine to raise CVP between 5-10 cm water. LV vent will be continuously regulated depending upon the amount of residual air showing in the left heart. When no air is seen on TEE monitoring in the left heart (LA, LV \& Aorta), half the calculated minute ventilation with 100% oxygen and a PEEP of 5 cm H2O will be started. De-airing will be continued and when the TEE shows no or minimal air in left heart, full ventilation with unchanged PEEP will be restored. The patient will be weaned successively from the CPB thereby ensuring that entire cardiac output is diverted through the native fully ventilated lungs. When TEE will show no air in the left heart, the de-airing will be considered complete and the time noted again (T3) (T3 - T2 = Post ejection de-airing time).
All cardiac cannulae including the LV vent will be left in situ but clamped, patient weaned completely from the cardiopulmonary bypass and monitored for residual air by TEE \& TCD for 10 minutes continually. The LV vent will be re-opened whenever the residual air in the left heart exceeds grade II. The frequency of theses measures will be noted in the protocol. If the patient has by now achieved 36 Celsius core temperature, the heart will be decannulated and CPB removed. Otherwise CPB will be restarted and patient warmed to 36 Celsius before final weaning and decannulation.
Study group ( CO2 insufflation ):
In these patients (n=10) the pleurae will not be opened. During aortic cross-clamp period the ventilator will be adjusted to provide dead space ventilation only i.e. 5cm PEEP, ventilator frequency 5/min and the minute ventilation = 1,5 liter. Fio2 = 50%. The operating field will be insufflated with CO2 at a flow rate of 10 L / minute starting 2 minutes before cardiac cannulation and continued until 10 minutes after termination of the CPB.
At the end of the cardioplegic arrest, the aortic root and the LV will be actively vented and the time noted down (T1). The LV preload will be successively increased by reducing the venous return from the heart-lung machine to raise CVP between 5-10 cm water. LV venting will be continued and when no air bubbles are seen in the left heart (LA, LV \& Aorta) under TEE monitoring, the calculated minute ventilation with 100% oxygen and PEEP of 5 cm H2O will be restored. De-airing will be continued and when no or minimal air is seen in the left heart the time will be noted down (T2) (T2 - T1 = Pre ejection de-airing time). Aortic cross-clamp will be released now and heart defibrillated to sinus or pacemaker induced rhythm and de-airing continued. At 35 Celsius body temperature, as measured from the thermistor in the urinary bladder, and with apparently good cardiac contraction the patient will be weaned successively from the CPB ensuring thereby that the entire cardiac output is diverted through the native fully ventilated lungs. Inotropic drugs or systemic arterial vasodilators will be used as and when necessary to achieve good cardiac contraction. When TEE will show no air in the left heart, the de-airing will be considered complete and the time noted again (T3) (T3 - T2 = Post ejection de-airing time). The patient will be weaned completely from the cardiopulmonary bypass and all cardiac cannulae including the LV vent will be left in situ but clamped. The patient will be monitored now for residual air by TEE \& TCD for 10 minutes continually. The LV vent will be re-opened whenever the residual air showing on TEE in the left heart exceeds grade II. The frequency of theses measures will be noted in the protocol. The C02 insufflations will continue until the 10- minute post CPB monitoring interval is completed. If patient by now has achieved 36 Celsius core temperature, the heart will be decannulated and CPB removed. Otherwise CPB will be restarted and patient warmed to 36 Celsius before final weaning and decannulation.
Trans-esophageal echocardiographic study (TEE):
After completion of the cardioplegic arrest and for 10 minutes after termination of the CPB, all the patients will be monitored by TEE for air in the left heart. The residual air showing on TEE after the termination of CPB will be quantified in 4 grades depending upon presence of air in LA, LV and aortic root during one cardiac cycle (grade 0 = no or occasional air in LA, grade 1 = air showing in LA only, grade 2 = air showing simultaneously in LA and LV, grade 3 = air showing simultaneously in LA, LV and the aortic root). The 10-minute post CPB TEE recording will be saved on a video-tape.
Trans-cranial echo-doppler study (TCD):
After release of the aortic cross clamp and for 10 minutes after the patient has been weaned off from the CPB, the patient will be continuously monitored for micro embolic signals by on-line automatic TCD placed on middle cerebral arteries.
Blood gases will be monitored in all patients as following:
Blood gas analysis from arterial \& venous blood of the patient every 15 minutes in the operating room in both groups until 15 minutes post CPB) - following attached tables (Anesthesia, Perfusion and TCD \& Invous monitoring)
Measurement of end-tidal PCO2 and volume of expired CO2 every 15 minutes after the patient is intubated and till the time patient leaves the operating room in both groups. (No measurements possible in the control group during cardioplegic arrest)
Blood gas analysis from arterial \& venous blood lines of the oxygenator and from the LV vent line every 15 minutes while the patient is on CPB in both groups.
Continuous on-line monitoring of CO2 content and PCO2 in the blood at the inflow and outflow ports of the oxygenator in both groups using CDI \& new machine. Variations in gas flow and the FiO2 needed to adjust PaCO2 to within a fixed desirable range will be recorded and extra blood gas sample will be taken whenever any such adjustment is made.
Alfa stat will be employed for blood gas analysis. A core temperature at 30 C will be used for all patients unless positively indicted.
- Conditions
- Aortic Valve Disorder
- Being tested
- Lund de-airing technique, carbon-dioxide insufflation
- Keywords
- Cardiac de-airing, CO2 insufflation, Air emboli, Trans cranial doppler, Intraoperative echocardiography
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lund de-airing techniqueProcedure or surgery
Also called cardiac de-airing, cardiac venting
In these patients the pleura will be opened on both sides and the ventilator will be disconnected before aorta is cross-clamped and cardioplegia administered. At the conclusion of the surgical procedure, the LV preload will first now be successively increased. When no air is seen on TEE monitoring in the left heart (LA, LV \& Aorta), half the calculated minute ventilation with 100% oxygen and a PEEP of 5 cm H2O will be started. Deairing will be continued and when the TEE shows no or minimal air in left heart, full ventilation with unchanged PEEP will be restored. The patient will be weaned successively from the CPB. When TEE will show no air in the left heart, the de-airing will be considered complete.
carbon-dioxide insufflationDrug
Also called Cardiac de-airing, Cardiac venting
In these patients (n=10) the pleurae will not be opened. During aortic cross-clamp period the ventilator will be adjusted to provide dead space ventilation only i.e. 5cm PEEP, ventilator frequency 5/min and the minute ventilation = 1,5 liter. Fio2 = 50%. The operating field will be insufflated with Co2 at a flow rate of 10 L / minute starting 2 minutes before cardiac cannulation and continued until 10 minutes after termination of the CPB.At the end of the cardioplegic arrest, the de-airing procedure is similar to that in the Lund de-airing group.
| Study group | Role | What they receive |
|---|---|---|
| Lund de-airing | Experimental | Lund de-airing technique Receives: Procedure: Lund de-airing technique |
| Carbon-dioxide insufflation | Active comparator | carbon-dioxide insufflation will be provided to the open mediastinal wound in a standardized manner Receives: Drug: carbon-dioxide insufflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD).
The number of air microemboli (also referred to as gaseous microembolic signals) was concomitantly counted in the right and left medial cerebral artery. The number of signals from the right and the left medial cerebral artery were summed, and presented as the total sum of the gaseous micromebolic signals from the right and left side. Counting of gaseous microembolic signals was done during three time intervals: Before cardiac ejection, after cardiac ejection and during 10 minutes after cardiopulmonary bypass.
Measured: Before cardiac ejection
Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD).
The number of air microemboli (also referred to as gaseous microembolic signals) was concomitantly counted in the right and left medial cerebral artery. The number of signals from the right and the left medial cerebral artery were summed, and presented as the total sum of the gaseous micromebolic signals from the right and left side. Counting of gaseous microembolic signals was done during three time intervals: Before cardiac ejection, after cardiac ejection and during 10 minutes after cardiopulmonary bypass.
Measured: After cardiac ejection
Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD).
The number of air microemboli (also referred to as gaseous microembolic signals) was concomitantly counted in the right and left medial cerebral artery. The number of signals from the right and the left medial cerebral artery were summed, and presented as the total sum of the gaseous micromebolic signals from the right and left side. Counting of gaseous microembolic signals was done during three time intervals: Before cardiac ejection, after cardiac ejection and during 10 minutes after cardiopulmonary bypass.
Measured: During 10 minutes after cardiopulmonary bypass
Number of Participants With <=Grade I Gas Emboli as Assessed by Trans-esophageal Echocardiography TEE).
Grade 0, no residual gas emboli; grade I, gas emboli observed in 1 of the 3 anatomic areas - left atrium, left ventricle or aortic root during 1 cardiac cycle; grade II, gas emboli observed simultaneously in 2 of the 3 anatomic areas during 1 cardiac cycle; grade III, gas emboli observed simultaneously in all 3 anatomic areas during 1 cardiac cycle.
Measured: 0-3 minutes after end of cardiopulmonary bypass
Number of Participants With <=Grade I Gas Emboli as Assessed by Trans-esophageal Echocardiography TEE).
Grade 0, no residual gas emboli; grade I, gas emboli observed in 1 of the 3 anatomic areas - left atrium, left ventricle or aortic root during 1 cardiac cycle; grade II, gas emboli observed simultaneously in 2 of the 3 anatomic areas during 1 cardiac cycle; grade III, gas emboli observed simultaneously in all 3 anatomic areas during 1 cardiac cycle.
Measured: 3-6 minutes after end of cardiopulmonary bypass
Number of Participants With <=Grade I Gas Emboli as Assessed by Trans-esophageal Echocardiography TEE).
Grade 0, no residual gas emboli; grade I, gas emboli observed in 1 of the 3 anatomic areas - left atrium, left ventricle or aortic root during 1 cardiac cycle; grade II, gas emboli observed simultaneously in 2 of the 3 anatomic areas during 1 cardiac cycle; grade III, gas emboli observed simultaneously in all 3 anatomic areas during 1 cardiac cycle.
Measured: 6-10 minutes after end of cardiopulmonary bypass
Secondary outcomes (5)
Total Time Required for De-airing
The total de-airing time as measured in minutes.
Measured: After removal of aortic cross-clamp to complete de-airing, an average of 11 minutes
De-airing Time Before Cardiac Ejection
Time in minutes starting at t1 (removal of aortic cross clamp) and ending at t2 (beginning of cardiac ejection).
Measured: Measured during intraoperative course
De-airing Time After Cardiac Ejection
The duration in minutes of the period after cardiac ejection to finished de-airing procedure.
Measured: During de-airing procedure
Oxygenator Gas Flow at 45 Minutes of CPB
The amount of carbon dioxide gas flow through the oxygenator was measured and compared between groups.
Measured: Intraoperative
pH at 45 Min of CPB
pH measured by arterial bloodgas at 45 minutes of CPB, comparison between groups
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve DisorderStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bansi Lal Koul, Lund University
- Investigators
- Bansi L Koul, MD, PhD, Principal investigator, Cardiothoracic Surgery, Heart & Lung Division, University Hospital Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934596
- Sponsor's protocol ID
- Lund de-airing technique
- Status last verified
- Oct 2013
- First submitted
- 7 Jul 2009
- Last updated
- 4 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Landenhed M, Al-Rashidi F, Blomquist S, Hoglund P, Pierre L, Koul B. Systemic effects of carbon dioxide insufflation technique for de-airing in left-sided cardiac surgery. J Thorac Cardiovasc Surg. 2014 Jan;147(1):295-300. doi: 10.1016/j.jtcvs.2012.11.010. Epub 2012 Dec 13.
PubMed 23246060Al-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 20817209
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CO2 Insufflation vs Lund De-airing Technique For Open Left Heart Surgery - Safety and Efficacy
- ClinicalTrials.gov ID
- NCT00934596
- Acronym / sponsor ID
- Lund de-airing technique
- Conditions
- Aortic Valve Disorder
- Keywords
- Cardiac de-airing, CO2 insufflation, Air emboli, Trans cranial doppler, Intraoperative echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 8 Jul 2009 (estimated)
- Results
- Posted 4 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate which of the two de-airing methods (CO2 insufflation vs. Lund de-airing technique) can shorten the left heart de-airing time and prevent or minimize cerebral air emboli during open surgery involving exposure of the left heart to the ambient air.
To evaluate the cost effectiveness and possible side effects of CO2 de-airing technique compared to Lund de-airing technique.
Detailed description
Study design:
Prospective, randomized and controlled study involving 20 patients, 10 in each group. The de-airing time and the efficiency of the techniques will be assessed by trans-esophageal echocardiography (TEE) and trans-cranial echo-doppler monitoring (TCD). The cardiologists analyzing the TEE recordings will be blinded to the de-airing technique used (the recorded videos will be analyzed at the end of the study). The TCD monitoring will be done by on-line automatic recording of the micro embolic signals (MES) from the right and or left middle cerebral arteries and performed by single surgeon. The CO2 insufflation of the operating field will be performed according to manufacturer's guide lines. During entire study course one type of extracorporeal perfusion system will be used.The study will be registered in the international database. A prior approval will be sought from the hospital ethical committee for the study.
Patient selection:
Patients planned for aortic valve/root replacement or repair will be selected for the study
Exclusion criteria:
Patients with known: a) chronic obstructive pulmonary disease, b) emphysema, c) previous thoracic or cardiac surgery, d) history of CVA or stroke and e) evidence of intraoperative pleural adhesions will be excluded from the study. Patients requiring internal mammary artery coronary bypass will also be excluded.
Patient consent:
A written consent previously approved by the hospital ethical committee will be obtained from all patients before they are enrolled in the study (enclosure 3).
De-airing procedure:
Enrolled patients will be assigned randomly to one of the two following groups:
Control group ( newly developed de-airing technique in Lund ) :
In these patients (n=10) the pleura will be opened on both sides and the ventilator will be disconnected before aorta is cross-clamped and cardioplegia administered. At the end of the cardioplegic arrest, the aortic root and the LV will be actively vented and aortic cross clamp released. The time will be noted down (T1). The heart will be defibrillated to sinus or pacemaker induced rhythm. The heart will be kept empty by the LV vent and ejection avoided as monitored by continual intraoperative TEE and systemic arterial pressure tracing. At 35 Celsius body temperature, as measured from the thermistor in the urinary bladder, and with apparently good cardiac contraction the de-airing will begin. Inotropic drugs or systemic arterial vasodilators will be used as and when necessary to achieve good cardiac contraction. The time will be noted down (T2) (T2 - T1 = Pre ejection de-airing time). The LV preload will first now be successively increased by reducing the venous return from the heart-lung machine to raise CVP between 5-10 cm water. LV vent will be continuously regulated depending upon the amount of residual air showing in the left heart. When no air is seen on TEE monitoring in the left heart (LA, LV \& Aorta), half the calculated minute ventilation with 100% oxygen and a PEEP of 5 cm H2O will be started. De-airing will be continued and when the TEE shows no or minimal air in left heart, full ventilation with unchanged PEEP will be restored. The patient will be weaned successively from the CPB thereby ensuring that entire cardiac output is diverted through the native fully ventilated lungs. When TEE will show no air in the left heart, the de-airing will be considered complete and the time noted again (T3) (T3 - T2 = Post ejection de-airing time).
All cardiac cannulae including the LV vent will be left in situ but clamped, patient weaned completely from the cardiopulmonary bypass and monitored for residual air by TEE \& TCD for 10 minutes continually. The LV vent will be re-opened whenever the residual air in the left heart exceeds grade II. The frequency of theses measures will be noted in the protocol. If the patient has by now achieved 36 Celsius core temperature, the heart will be decannulated and CPB removed. Otherwise CPB will be restarted and patient warmed to 36 Celsius before final weaning and decannulation.
Study group ( CO2 insufflation ):
In these patients (n=10) the pleurae will not be opened. During aortic cross-clamp period the ventilator will be adjusted to provide dead space ventilation only i.e. 5cm PEEP, ventilator frequency 5/min and the minute ventilation = 1,5 liter. Fio2 = 50%. The operating field will be insufflated with CO2 at a flow rate of 10 L / minute starting 2 minutes before cardiac cannulation and continued until 10 minutes after termination of the CPB.
At the end of the cardioplegic arrest, the aortic root and the LV will be actively vented and the time noted down (T1). The LV preload will be successively increased by reducing the venous return from the heart-lung machine to raise CVP between 5-10 cm water. LV venting will be continued and when no air bubbles are seen in the left heart (LA, LV \& Aorta) under TEE monitoring, the calculated minute ventilation with 100% oxygen and PEEP of 5 cm H2O will be restored. De-airing will be continued and when no or minimal air is seen in the left heart the time will be noted down (T2) (T2 - T1 = Pre ejection de-airing time). Aortic cross-clamp will be released now and heart defibrillated to sinus or pacemaker induced rhythm and de-airing continued. At 35 Celsius body temperature, as measured from the thermistor in the urinary bladder, and with apparently good cardiac contraction the patient will be weaned successively from the CPB ensuring thereby that the entire cardiac output is diverted through the native fully ventilated lungs. Inotropic drugs or systemic arterial vasodilators will be used as and when necessary to achieve good cardiac contraction. When TEE will show no air in the left heart, the de-airing will be considered complete and the time noted again (T3) (T3 - T2 = Post ejection de-airing time). The patient will be weaned completely from the cardiopulmonary bypass and all cardiac cannulae including the LV vent will be left in situ but clamped. The patient will be monitored now for residual air by TEE \& TCD for 10 minutes continually. The LV vent will be re-opened whenever the residual air showing on TEE in the left heart exceeds grade II. The frequency of theses measures will be noted in the protocol. The C02 insufflations will continue until the 10- minute post CPB monitoring interval is completed. If patient by now has achieved 36 Celsius core temperature, the heart will be decannulated and CPB removed. Otherwise CPB will be restarted and patient warmed to 36 Celsius before final weaning and decannulation.
Trans-esophageal echocardiographic study (TEE):
After completion of the cardioplegic arrest and for 10 minutes after termination of the CPB, all the patients will be monitored by TEE for air in the left heart. The residual air showing on TEE after the termination of CPB will be quantified in 4 grades depending upon presence of air in LA, LV and aortic root during one cardiac cycle (grade 0 = no or occasional air in LA, grade 1 = air showing in LA only, grade 2 = air showing simultaneously in LA and LV, grade 3 = air showing simultaneously in LA, LV and the aortic root). The 10-minute post CPB TEE recording will be saved on a video-tape.
Trans-cranial echo-doppler study (TCD):
After release of the aortic cross clamp and for 10 minutes after the patient has been weaned off from the CPB, the patient will be continuously monitored for micro embolic signals by on-line automatic TCD placed on middle cerebral arteries.
Blood gases will be monitored in all patients as following:
Blood gas analysis from arterial \& venous blood of the patient every 15 minutes in the operating room in both groups until 15 minutes post CPB) - following attached tables (Anesthesia, Perfusion and TCD \& Invous monitoring)
Measurement of end-tidal PCO2 and volume of expired CO2 every 15 minutes after the patient is intubated and till the time patient leaves the operating room in both groups. (No measurements possible in the control group during cardioplegic arrest)
Blood gas analysis from arterial \& venous blood lines of the oxygenator and from the LV vent line every 15 minutes while the patient is on CPB in both groups.
Continuous on-line monitoring of CO2 content and PCO2 in the blood at the inflow and outflow ports of the oxygenator in both groups using CDI \& new machine. Variations in gas flow and the FiO2 needed to adjust PaCO2 to within a fixed desirable range will be recorded and extra blood gas sample will be taken whenever any such adjustment is made.
Alfa stat will be employed for blood gas analysis. A core temperature at 30 C will be used for all patients unless positively indicted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lund de-airing | Experimental | Procedure: Lund de-airing techniqueLund de-airing technique |
| Carbon-dioxide insufflation | Active comparator | Drug: carbon-dioxide insufflationcarbon-dioxide insufflation will be provided to the open mediastinal wound in a standardized manner |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients planned for aortic valve/root replacement or repair will be selected for the study
Key exclusion criteria (7 listed)
- Patients with known
- chronic obstructive pulmonary disease,
- emphysema,
- previous thoracic or cardiac surgery,
- history of CVA or stroke and
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 |
|---|---|---|
| Lund de-airing techniqueAlso: cardiac de-airing, cardiac ventingIn these patients the pleura will be opened on both sides and the ventilator will be disconnected before aorta is cross-clamped and cardioplegia administered. At the conclusion of the surgical procedure, the LV preload will first now be successively increased. When no air is seen on TEE monitoring in the left heart (LA, LV \& Aorta), half the calculated minute ventilation with 100% oxygen and a PEEP of 5 cm H2O will be started. Deairing will be continued and when the TEE shows no or minimal air in left heart, full ventilation with unchanged PEEP will be restored. The patient will be weaned successively from the CPB. When TEE will show no air in the left heart, the de-airing will be considered complete. | Procedure or surgery | Lund de-airing |
| carbon-dioxide insufflationAlso: Cardiac de-airing, Cardiac ventingIn these patients (n=10) the pleurae will not be opened. During aortic cross-clamp period the ventilator will be adjusted to provide dead space ventilation only i.e. 5cm PEEP, ventilator frequency 5/min and the minute ventilation = 1,5 liter. Fio2 = 50%. The operating field will be insufflated with Co2 at a flow rate of 10 L / minute starting 2 minutes before cardiac cannulation and continued until 10 minutes after termination of the CPB.At the end of the cardioplegic arrest, the de-airing procedure is similar to that in the Lund de-airing group. | Drug | Carbon-dioxide insufflation |
Primary outcome
Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD).
Time frame: Before cardiac ejection
The number of air microemboli (also referred to as gaseous microembolic signals) was concomitantly counted in the right and left medial cerebral artery. The number of signals from the right and the left medial cerebral artery were summed, and presented as the total sum of the gaseous micromebolic signals from the right and left side. Counting of gaseous microembolic signals was done during three time intervals: Before cardiac ejection, after cardiac ejection and during 10 minutes after cardiopulmonary bypass.
Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD).
Time frame: After cardiac ejection
The number of air microemboli (also referred to as gaseous microembolic signals) was concomitantly counted in the right and left medial cerebral artery. The number of signals from the right and the left medial cerebral artery were summed, and presented as the total sum of the gaseous micromebolic signals from the right and left side. Counting of gaseous microembolic signals was done during three time intervals: Before cardiac ejection, after cardiac ejection and during 10 minutes after cardiopulmonary bypass.
Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD).
Time frame: During 10 minutes after cardiopulmonary bypass
The number of air microemboli (also referred to as gaseous microembolic signals) was concomitantly counted in the right and left medial cerebral artery. The number of signals from the right and the left medial cerebral artery were summed, and presented as the total sum of the gaseous micromebolic signals from the right and left side. Counting of gaseous microembolic signals was done during three time intervals: Before cardiac ejection, after cardiac ejection and during 10 minutes after cardiopulmonary bypass.
Number of Participants With <=Grade I Gas Emboli as Assessed by Trans-esophageal Echocardiography TEE).
Time frame: 0-3 minutes after end of cardiopulmonary bypass
Grade 0, no residual gas emboli; grade I, gas emboli observed in 1 of the 3 anatomic areas - left atrium, left ventricle or aortic root during 1 cardiac cycle; grade II, gas emboli observed simultaneously in 2 of the 3 anatomic areas during 1 cardiac cycle; grade III, gas emboli observed simultaneously in all 3 anatomic areas during 1 cardiac cycle.
Number of Participants With <=Grade I Gas Emboli as Assessed by Trans-esophageal Echocardiography TEE).
Time frame: 3-6 minutes after end of cardiopulmonary bypass
Grade 0, no residual gas emboli; grade I, gas emboli observed in 1 of the 3 anatomic areas - left atrium, left ventricle or aortic root during 1 cardiac cycle; grade II, gas emboli observed simultaneously in 2 of the 3 anatomic areas during 1 cardiac cycle; grade III, gas emboli observed simultaneously in all 3 anatomic areas during 1 cardiac cycle.
Number of Participants With <=Grade I Gas Emboli as Assessed by Trans-esophageal Echocardiography TEE).
Time frame: 6-10 minutes after end of cardiopulmonary bypass
Grade 0, no residual gas emboli; grade I, gas emboli observed in 1 of the 3 anatomic areas - left atrium, left ventricle or aortic root during 1 cardiac cycle; grade II, gas emboli observed simultaneously in 2 of the 3 anatomic areas during 1 cardiac cycle; grade III, gas emboli observed simultaneously in all 3 anatomic areas during 1 cardiac cycle.
5 secondary outcomes
Total Time Required for De-airing
Time frame: After removal of aortic cross-clamp to complete de-airing, an average of 11 minutes
De-airing Time Before Cardiac Ejection
Time frame: Measured during intraoperative course
De-airing Time After Cardiac Ejection
Time frame: During de-airing procedure
Oxygenator Gas Flow at 45 Minutes of CPB
Time frame: Intraoperative
pH at 45 Min of CPB
Time frame: Intraoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23246060Landenhed M, Al-Rashidi F, Blomquist S, Hoglund P, Pierre L, Koul B. Systemic effects of carbon dioxide insufflation technique for de-airing in left-sided cardiac surgery. J Thorac Cardiovasc Surg. 2014 Jan;147(1):295-300. doi: 10.1016/j.jtcvs.2012.11.010. Epub 2012 Dec 13.
- Derived from this study: 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.
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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.
Bansi L Koul, MD, PhD principal investigator
Cardiothoracic Surgery, Heart & Lung Division, University Hospital Lund, Sweden
Questions about this trial
What is this clinical trial studying?
A study testing Lund de-airing technique and carbon-dioxide insufflation in people with Aortic Valve Disorder, run by Lund University.
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 1 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: finished, as of the sponsor's last update on 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 4 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD). (time frame: Before cardiac ejection). The study lists 6 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 NCT00934596, which also lists 2 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 4 Dec 2013.