Complication of Surgical ProcedureNCT01757704
Factors Responsible for the Effectiveness of the Lund De-airing Technique
A study testing Open pleurae & conventional filling of heart and Intact pleurae & staged filling of heart in people with Complication of Surgical Procedure, run by Lund University at 1 site in Sweden.
Trial summary
The Lund de-airing technique is employed for cardiac de-airing in open left heart surgery. It consists of two main elements namely, opening of both pleura after the patient is on CPB (cardiopulmonary bypass)and disconnection of the ventilator before opening the left heart to ensure bilateral pulmonary collapse and a… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Complication of Surgical Procedure
- What is being tested?
- Open pleurae & conventional filling of heart and Intact pleurae & staged filling of heart
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2012to Jan 2014
- 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 replacement with or without coronary vein bypass grafts
Who cannot join
- Significant chronic obstructive pulmonary disease and emphysema
- Previous history of thoracic or cardiac surgery
- Patients requiring internal mammary artery harvesting
- Unilateral or bilateral pulmonary adhesions to chest wall
- Previous radiation to the chest
- Intraoperative Exclusion Criteria:
Show all 9Show fewer
- Inability to obtain adequate bilateral Trans-cranial Echo-doppler signals
- Adherent pleurae
- Accidental opening of the pleurae
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Factors Responsible for the Effectiveness of the Lund Technique for De-airing Following Open Left Heart Surgery.
The Lund de-airing technique is employed for cardiac de-airing in open left heart surgery. It consists of two main elements namely, opening of both pleura after the patient is on CPB (cardiopulmonary bypass)and disconnection of the ventilator before opening the left heart to ensure bilateral pulmonary collapse and a staged filling of the heart at termination of the CPB. The aim of this study is to analyze in a randomized manner two groups of patients to establish if one or both components are of primary importance for the effectiveness of the de-airing technique.
Read the detailed description
Patients planned for open left heart surgery, mainly aortic valve replacement, will be included in the study. Patients with aortic valve replacement and concomitant coronary artery bypass with vein grafts only can also be included.
Exclusion criteria are; significant chronic obstructive pulmonary disease/emphysema, significant (>50%)carotid artery disease, need of concomitant internal mammary harvesting, prior cardiac or pulmonary surgery, pulmonary adhesions preventing pulmonary collapse, previous radiation to the chest and prior severe chest trauma. Intraoperative exclusion criteria are; failure to obtain adequate bilateral Trans-cranial Echo-Doppler signals from the medial cerebral arteries, finding of adherent pleurae and accidental opening of the pleurae.
Twenty patients will be randomized to two groups:
Group I: Intact pleura bilaterally, disconnection of the ventilator during cardiopulmonary bypass (CPB), followed by staged filling of the heart.
Group II: Open pleura bilaterally, disconnection of the ventilator during cardiopulmonary bypass to ensure bilateral pulmonary collapse followed by conventional filling of the heart.
Data will be compared to a third historical control group, consisting of ten patients with open pleurae with the ventilator disconnected followed by staged filling of the heart.
Primary outcomes:
- Duration of the de-airing procedure from the release of the aortic cross clamp to finished de-airing.
- Air microemboli to the brain registered on-line as gaseous microembolic signals on Trans-cranial Echo-Doppler (TCD). The sum of signals from the right and left middle cerebral artery are registered during the following time periods; from the release of the aortic cross clamp to start of cardiac ejection, from cardiac ejection to finished de-airing, and during ten minutes after finished de-airing.
- Magnitude of residual air emboli in the heart after finished de-airing as monitored by Trans-esophageal Echocardiography (TEE) with a Three-chamber view. The severity of residual air is classified in four grades after the appearance of visible air on TEE in left atrium (LA), left ventricle (LV) and aortic root (AO)as follows; Grade 0: no residual air, grade I: gas emboli detected in one of three anatomic areas during one cardiac cycle, grade II: gas emboli detected simultaneously in two of three anatomic areas during one cardiac cycle; grade III: gas emboli detected in all three anatomic areas during one cardiac cycle.
- Conditions
- Complication of Surgical Procedure
- Being tested
- Open pleurae & conventional filling of heart, Intact pleurae & staged filling of heart
- Keywords
- Cardiac de-airing, Air emboli, Trans-cranial Echo-Doppler, Intraoperative Trans-esophageal Echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open pleurae & conventional filling of heartProcedure or surgery
Also called Cardiac de-airing, Cardiac venting
After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on Trans-esophageal echocardiography, the patient is weaned from cardiopulmonary bypass.
Intact pleurae & staged filling of heartProcedure or surgery
Also called Cardiac de-airing, Cardiac venting
After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocardiography. Thereafter the lungs are ventilated with 50% of the estimated lung minute volume and 5 cm positive end-expiratory pressure and cardiac filling and de-airing continued. If no air is seen in the left heart full ventilation is started and the patient is weaned from cardiopulmonary bypass.
| Study group | Role | What they receive |
|---|---|---|
| Open pleurae & conventional filling of heart | Experimental | In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral pulmonary collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes. Receives: Procedure: Open pleurae & conventional filling of heart |
| Intact pleurae & staged filling of heart | Experimental | In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes. Receives: Procedure: Intact pleurae & staged filling of heart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery
Cerebral air emboli will be assessed quantitatively by On-line counting of gaseous microembolic signals (MES) by Trans-cranial Echo-Doppler (TCD) monitoring of the right and left middle cerebral artery. The sum of the gaseous microembolic signals registered from the right and left middle cerebral artery will be reported.
Measured: Time from the release of the aortic crossclamp to cardiac ejection, an average of 10-15 minutes
Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery
Cerebral air emboli will be assessed quantitatively by On-line counting of gaseous microembolic signals (MES) by Trans-cranial Echo-Doppler (TCD) monitoring of the right and left middle cerebral artery. The sum of the gaseous microembolic signals registered from the right and left middle cerebral artery will be reported.
Measured: Time from cardiac ejection to finished de-airing, an average of 5-10 minutes
Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery
Cerebral air emboli will be assessed quantitatively by On-line counting of gaseous microembolic signals (MES) by Trans-cranial Echo-Doppler (TCD) monitoring of the right and left middle cerebral artery. The sum of the gaseous microembolic signals registered from the right and left middle cerebral artery will be reported.
Measured: Period of ten minutes after finished de-airing
Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.
The severity of residual air emboli in three anatomic areas; left atrium, left ventricle and aortic root, is assessed by Trans-esophageal Echocardiography (TEE) and classified in grade 0-3 as follows, Grade o: no residual air; grade I: gas emboli detected in one of three anatomic areas during one cardiac cycle; grade II: gas emboli detected simultaneously in two of three anatomic areas during one cardiac cycle; grade III: gas emboli detected simultaneously in all three anatomic areas during one cardiac cycle.
Measured: 0-3 minutes after finished de-airing
Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.
The severity of residual air emboli in three anatomic areas; left atrium, left ventricle and aortic root, is assessed by Trans-esophageal Echocardiography (TEE) and classified in grade 0-3 as follows, Grade o: no residual air; grade I: gas emboli detected in one of three anatomic areas during one cardiac cycle; grade II: gas emboli detected simultaneously in two of three anatomic areas during one cardiac cycle; grade III: gas emboli detected simultaneously in all three anatomic areas during one cardiac cycle.
Measured: 3-6 minutes after finished de-airing
Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.
The severity of residual air emboli in three anatomic areas; left atrium, left ventricle and aortic root, is assessed by Trans-esophageal Echocardiography (TEE) and classified in grade 0-3 as follows, Grade o: no residual air; grade I: gas emboli detected in one of three anatomic areas during one cardiac cycle; grade II: gas emboli detected simultaneously in two of three anatomic areas during one cardiac cycle; grade III: gas emboli detected simultaneously in all three anatomic areas during one cardiac cycle.
Measured: 6-10 minutes after finished de-airing
Duration of the De-airing Procedure
The de-airing procedure is deemed completed when the Trans-esophageal Echocardiography (TEE) no longer visualizes air emboli in the heart Chambers. The duration is likely to vary between individuals and reflects the complexity of the de-airing procedure.
Measured: Time from release of aortic crossclamp to finished de-airing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2013
- Study completionJan 2014
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 Complication of Surgical ProcedureStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- 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 Koul, MD, PhD, Principal investigator, Cardiothoracic Surgery, Skåne University Hospital Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757704
- Sponsor's protocol ID
- BKML-003
- Status last verified
- Jan 2014
- First submitted
- 22 Sep 2012
- Last updated
- 10 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Al-Rashidi F, Blomquist S, Hoglund P, Meurling C, Roijer A, Koul B. A new de-airing technique that reduces systemic microemboli during open surgery: a prospective controlled study. J Thorac Cardiovasc Surg. 2009 Jul;138(1):157-62. doi: 10.1016/j.jtcvs.2009.02.037.
PubMed 19577073Al-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 10 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Responsible for the Effectiveness of the Lund Technique for De-airing Following Open Left Heart Surgery.
- ClinicalTrials.gov ID
- NCT01757704
- Acronym / sponsor ID
- BKML-003
- Conditions
- Complication of Surgical Procedure
- Keywords
- Cardiac de-airing, Air emboli, Trans-cranial Echo-Doppler, Intraoperative Trans-esophageal Echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 31 Dec 2012 (estimated)
- Results
- Posted 6 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Lund de-airing technique is employed for cardiac de-airing in open left heart surgery. It consists of two main elements namely, opening of both pleura after the patient is on CPB (cardiopulmonary bypass)and disconnection of the ventilator before opening the left heart to ensure bilateral pulmonary collapse and a staged filling of the heart at termination of the CPB. The aim of this study is to analyze in a randomized manner two groups of patients to establish if one or both components are of primary importance for the effectiveness of the de-airing technique.
Detailed description
Patients planned for open left heart surgery, mainly aortic valve replacement, will be included in the study. Patients with aortic valve replacement and concomitant coronary artery bypass with vein grafts only can also be included.
Exclusion criteria are; significant chronic obstructive pulmonary disease/emphysema, significant (>50%)carotid artery disease, need of concomitant internal mammary harvesting, prior cardiac or pulmonary surgery, pulmonary adhesions preventing pulmonary collapse, previous radiation to the chest and prior severe chest trauma. Intraoperative exclusion criteria are; failure to obtain adequate bilateral Trans-cranial Echo-Doppler signals from the medial cerebral arteries, finding of adherent pleurae and accidental opening of the pleurae.
Twenty patients will be randomized to two groups:
Group I: Intact pleura bilaterally, disconnection of the ventilator during cardiopulmonary bypass (CPB), followed by staged filling of the heart.
Group II: Open pleura bilaterally, disconnection of the ventilator during cardiopulmonary bypass to ensure bilateral pulmonary collapse followed by conventional filling of the heart.
Data will be compared to a third historical control group, consisting of ten patients with open pleurae with the ventilator disconnected followed by staged filling of the heart.
Primary outcomes:
- Duration of the de-airing procedure from the release of the aortic cross clamp to finished de-airing.
- Air microemboli to the brain registered on-line as gaseous microembolic signals on Trans-cranial Echo-Doppler (TCD). The sum of signals from the right and left middle cerebral artery are registered during the following time periods; from the release of the aortic cross clamp to start of cardiac ejection, from cardiac ejection to finished de-airing, and during ten minutes after finished de-airing.
- Magnitude of residual air emboli in the heart after finished de-airing as monitored by Trans-esophageal Echocardiography (TEE) with a Three-chamber view. The severity of residual air is classified in four grades after the appearance of visible air on TEE in left atrium (LA), left ventricle (LV) and aortic root (AO)as follows; Grade 0: no residual air, grade I: gas emboli detected in one of three anatomic areas during one cardiac cycle, grade II: gas emboli detected simultaneously in two of three anatomic areas during one cardiac cycle; grade III: gas emboli detected in all three anatomic areas during one cardiac cycle.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open pleurae & conventional filling of heart | Experimental | Procedure: Open pleurae & conventional filling of heartIn this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral pulmonary collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes. |
| Intact pleurae & staged filling of heart | Experimental | Procedure: Intact pleurae & staged filling of heartIn this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes. |
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 replacement with or without coronary vein bypass grafts
Key exclusion criteria (9 listed)
- Significant chronic obstructive pulmonary disease and emphysema
- Previous history of thoracic or cardiac surgery
- Patients requiring internal mammary artery harvesting
- Unilateral or bilateral pulmonary adhesions to chest wall
- Previous radiation to the chest
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 |
|---|---|---|
| Open pleurae & conventional filling of heartAlso: Cardiac de-airing, Cardiac ventingAfter completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on Trans-esophageal echocardiography, the patient is weaned from cardiopulmonary bypass. | Procedure or surgery | Open pleurae & conventional filling of heart |
| Intact pleurae & staged filling of heartAlso: Cardiac de-airing, Cardiac ventingAfter the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocardiography. Thereafter the lungs are ventilated with 50% of the estimated lung minute volume and 5 cm positive end-expiratory pressure and cardiac filling and de-airing continued. If no air is seen in the left heart full ventilation is started and the patient is weaned from cardiopulmonary bypass. | Procedure or surgery | Intact pleurae & staged filling of heart |
Primary outcome
Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery
Time frame: Time from the release of the aortic crossclamp to cardiac ejection, an average of 10-15 minutes
Cerebral air emboli will be assessed quantitatively by On-line counting of gaseous microembolic signals (MES) by Trans-cranial Echo-Doppler (TCD) monitoring of the right and left middle cerebral artery. The sum of the gaseous microembolic signals registered from the right and left middle cerebral artery will be reported.
Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery
Time frame: Time from cardiac ejection to finished de-airing, an average of 5-10 minutes
Cerebral air emboli will be assessed quantitatively by On-line counting of gaseous microembolic signals (MES) by Trans-cranial Echo-Doppler (TCD) monitoring of the right and left middle cerebral artery. The sum of the gaseous microembolic signals registered from the right and left middle cerebral artery will be reported.
Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery
Time frame: Period of ten minutes after finished de-airing
Cerebral air emboli will be assessed quantitatively by On-line counting of gaseous microembolic signals (MES) by Trans-cranial Echo-Doppler (TCD) monitoring of the right and left middle cerebral artery. The sum of the gaseous microembolic signals registered from the right and left middle cerebral artery will be reported.
Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.
Time frame: 0-3 minutes after finished de-airing
The severity of residual air emboli in three anatomic areas; left atrium, left ventricle and aortic root, is assessed by Trans-esophageal Echocardiography (TEE) and classified in grade 0-3 as follows, Grade o: no residual air; grade I: gas emboli detected in one of three anatomic areas during one cardiac cycle; grade II: gas emboli detected simultaneously in two of three anatomic areas during one cardiac cycle; grade III: gas emboli detected simultaneously in all three anatomic areas during one cardiac cycle.
Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.
Time frame: 3-6 minutes after finished de-airing
The severity of residual air emboli in three anatomic areas; left atrium, left ventricle and aortic root, is assessed by Trans-esophageal Echocardiography (TEE) and classified in grade 0-3 as follows, Grade o: no residual air; grade I: gas emboli detected in one of three anatomic areas during one cardiac cycle; grade II: gas emboli detected simultaneously in two of three anatomic areas during one cardiac cycle; grade III: gas emboli detected simultaneously in all three anatomic areas during one cardiac cycle.
Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.
Time frame: 6-10 minutes after finished de-airing
The severity of residual air emboli in three anatomic areas; left atrium, left ventricle and aortic root, is assessed by Trans-esophageal Echocardiography (TEE) and classified in grade 0-3 as follows, Grade o: no residual air; grade I: gas emboli detected in one of three anatomic areas during one cardiac cycle; grade II: gas emboli detected simultaneously in two of three anatomic areas during one cardiac cycle; grade III: gas emboli detected simultaneously in all three anatomic areas during one cardiac cycle.
Duration of the De-airing Procedure
Time frame: Time from release of aortic crossclamp to finished de-airing
The de-airing procedure is deemed completed when the Trans-esophageal Echocardiography (TEE) no longer visualizes air emboli in the heart Chambers. The duration is likely to vary between individuals and reflects the complexity of the de-airing procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19577073Al-Rashidi F, Blomquist S, Hoglund P, Meurling C, Roijer A, Koul B. A new de-airing technique that reduces systemic microemboli during open surgery: a prospective controlled study. J Thorac Cardiovasc Surg. 2009 Jul;138(1):157-62. doi: 10.1016/j.jtcvs.2009.02.037.
- 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.
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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 Koul, MD, PhD principal investigator
Cardiothoracic Surgery, Skåne University Hospital Lund, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open pleurae & conventional filling of heart and Intact pleurae & staged filling of heart in people with Complication of Surgical Procedure, run by Lund University 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 1 inclusion and 9 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 10 Feb 2014. 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?
Yes. Results are posted in the registry (first posted 6 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?
Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery (time frame: Time from the release of the aortic crossclamp to cardiac ejection, an average of 10-15 minutes). The study lists 7 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 NCT01757704, 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 10 Feb 2014.