CO2 Versus Lund De-airing Technique in Heart Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bansi Lal Koul, Lund University
ClinicalTrials.gov Identifier:
NCT00934596
First received: July 7, 2009
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Aortic Valve Disorder
Procedure: Lund de-airing technique
Drug: carbon-dioxide insufflation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: CO2 Insufflation vs Lund De-airing Technique For Open Left Heart Surgery - Safety and Efficacy

Resource links provided by NLM:


Further study details as provided by Lund University:

Primary Outcome Measures:
  • Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD). [ Time Frame: Before cardiac ejection ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Total Time Required for De-airing [ Time Frame: After removal of aortic cross-clamp to complete de-airing, an average of 11 minutes ] [ Designated as safety issue: No ]
    The total de-airing time as measured in minutes.

  • De-airing Time Before Cardiac Ejection [ Time Frame: Measured during intraoperative course ] [ Designated as safety issue: No ]
    Time in minutes starting at t1 (removal of aortic cross clamp) and ending at t2 (beginning of cardiac ejection).

  • De-airing Time After Cardiac Ejection [ Time Frame: During de-airing procedure ] [ Designated as safety issue: No ]
    The duration in minutes of the period after cardiac ejection to finished de-airing procedure.

  • Oxygenator Gas Flow at 45 Minutes of CPB [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
    The amount of carbon dioxide gas flow through the oxygenator was measured and compared between groups.

  • pH at 45 Min of CPB [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
    pH measured by arterial bloodgas at 45 minutes of CPB, comparison between groups


Enrollment: 20
Study Start Date: June 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lund de-airing
Lund de-airing technique
Procedure: Lund de-airing technique
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.
Other Names:
  • cardiac de-airing
  • cardiac venting
Active Comparator: Carbon-dioxide insufflation
carbon-dioxide insufflation will be provided to the open mediastinal wound in a standardized manner
Drug: carbon-dioxide 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 de-airing procedure is similar to that in the Lund de-airing group.
Other Names:
  • Cardiac de-airing
  • Cardiac venting

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients planned for aortic valve/root replacement or repair will be selected for the study

Exclusion Criteria:

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00934596

Sponsors and Collaborators
Lund University
Investigators
Principal Investigator: Bansi L Koul, MD, PhD Cardiothoracic Surgery, Heart & Lung Division, University Hospital Lund, Sweden
  More Information

No publications provided by Lund University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bansi Lal Koul, Chief Surgeon and Associate Professor, Lund University
ClinicalTrials.gov Identifier: NCT00934596     History of Changes
Other Study ID Numbers: Lund de-airing technique
Study First Received: July 7, 2009
Results First Received: June 27, 2013
Last Updated: October 7, 2013
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Lund University:
Cardiac de-airing
CO2 insufflation
Air emboli
Trans cranial doppler
Intraoperative echocardiography

ClinicalTrials.gov processed this record on July 29, 2014