Factors Responsible for the Effectiveness of the Lund De-airing Technique

NCT01757704 | Completed Results

• 1 other identifier: BKML-003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Complication of Surgical Procedure

Keywords

Cardiac de-airing; Air emboli; Trans-cranial Echo-Doppler; Intraoperative Trans-esophageal Echocardiography

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  Time from release of aortic crossclamp to finished de-airing

Study Arms (2)

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.

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.

Procedure: Intact pleurae & staged filling of heart

Interventions

Open pleurae & conventional filling of heart PROCEDURE

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.

Also known as: Cardiac de-airing, Cardiac venting

Open pleurae & conventional filling of heart

Intact pleurae & staged filling of heart PROCEDURE

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.

Also known as: Cardiac de-airing, Cardiac venting

Intact pleurae & staged filling of heart

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 replacement with or without coronary vein bypass grafts

You may not qualify if:

• 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
• Inability to obtain adequate bilateral Trans-cranial Echo-doppler signals
• Adherent pleurae
• Accidental opening of the pleurae

Sponsors & Collaborators

• Lund University: lead

Study Sites (1)

Lund University

Lund, Skåne County, 22350, Sweden

Location

Related Publications (2)

• 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.

  PMID: 19577073 BACKGROUND

• 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 BACKGROUND

Limitations and Caveats

This study is a small single center study. Though randomized and controlled, the surgeon and anesthesiologist were not blinded to which arm a participant belonged to during the course of surgery.

Results Point of Contact

• Title: Dr. Bansi Koul
• Organization: Lunds University

bansi.koul@skane.se

+4646171649

Study Officials

• Bansi Koul, MD, PhD

  Cardiothoracic Surgery, Skåne University Hospital Lund, Sweden

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Med dr. Ph. D.

Study Record Dates

• First Submitted: September 22, 2012
• First Posted: December 31, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: February 10, 2014
• Results First Posted: December 6, 2013

Record last verified: 2014-01

Locations

SE (1)