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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: December 21, 2012
Last verified: December 2012
History of Changes
  Purpose

To evaluate which of the two de-airing methods (Co2 insufflation vs. Lund de-airing technique) can shorten the left heart deairing time and prevent or minimize cerebral air emboli during open surgery involving exposure of the left heart to the ambient air.

To evaluate the CO2 De-airing technique cost effectiveness and possible side effects 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:

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Further study details as provided by Lund University:

Primary Outcome Measures:
  • No. of air microemboli registered on-line over middle cerebral artery [ Time Frame: During cardiac de-airing and 10 minutes directly after ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Total time required for de-airing [ Time Frame: After completion of heart surgery and before de-airing is complete ] [ Designated as safety issue: No ]

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
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
Last Updated: December 21, 2012
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 June 17, 2013