CO2 Versus Lund De-airing Technique in Heart Surgery

NCT00934596 | Completed Results

• 1 other identifier: Lund de-airing technique
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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. To evaluate the cost effectiveness and possible side effects of CO2 de-airing technique compared to Lund de-airing technique.

Conditions

Aortic Valve Disorder

Keywords

Cardiac de-airing; CO2 insufflation; Air emboli; Trans cranial doppler; Intraoperative echocardiography

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  6-10 minutes after end of cardiopulmonary bypass

Secondary Outcomes (5)

• Total Time Required for De-airing

  After removal of aortic cross-clamp to complete de-airing, an average of 11 minutes

• De-airing Time Before Cardiac Ejection

  Measured during intraoperative course

• De-airing Time After Cardiac Ejection

  During de-airing procedure

• Oxygenator Gas Flow at 45 Minutes of CPB

  Intraoperative

• pH at 45 Min of CPB

  Intraoperative

Study Arms (2)

Lund de-airing

EXPERIMENTAL

Lund de-airing technique

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

Drug: carbon-dioxide insufflation

Interventions

Lund de-airing technique PROCEDURE

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.

Also known as: cardiac de-airing, cardiac venting

Lund de-airing

carbon-dioxide insufflation DRUG

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.

Also known as: Cardiac de-airing, Cardiac venting

Carbon-dioxide insufflation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lund University: lead

Related Publications (2)

• 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.

  PMID: 23246060 DERIVED

• Al-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.

  PMID: 20817209 DERIVED

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

This study included a total of 20 patients randomized to one of two groups with ten patients in each arms. The small number of study objects might be a potential limitation.

Results Point of Contact

• Title: Dr. Bansi Koul MD, PhD, Principal Investigator
• Organization: Cardiothoracic Surgery, Skåne University Hospital Lund

bansi.koul@skane.se

+46 46 171649

Study Officials

• Bansi L Koul, MD, PhD

  Cardiothoracic Surgery, Heart & Lung Division, University Hospital Lund, Sweden

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Surgeon and Associate Professor

Study Record Dates

• First Submitted: July 7, 2009
• First Posted: July 8, 2009
• Study Start: June 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: December 4, 2013
• Results First Posted: December 4, 2013

Record last verified: 2013-10