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Completed

NCT Number: NCT02119871

Comparative Effectiveness of Unilateral vs. Bilateral Pulmonary Collapse in Cardiac De-airing

To compare the effectiveness of unilateral pulmonary collapse (right lung) to bilateral pulmonary collapse for cardiac de-airing in open left-sided heart surgery.

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Key information

Conditions

Brain Ischemia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Reduction of Cerebral Air Emboli Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiothoracic Department, Skane University Hospital

Lund, Lund, Skåne, 221 85, Sweden

About this study

Effective removal of air from the heart before termination of cardiopulmonary bypass (CPB) is vital in open left heart surgery. Bilateral collapse of the lungs during cardiopulmonary bypass decreases the duration of the de-airing procedure, decreases residual air emboli monitored on Trans-esophageal Echocardiography (TEE) and decreases gaseous cerebral microemboli (MES) monitored by Trans-cranial Echo-Doppler (TCD) when compared to expanded lungs during (CPB). Induced pulmonary collapse by opening of the pleura and disconnection of the patient from the ventilator during CPB decreases the amount of air that can enter the pulmonary veins. Not all surgeons wish to induce lung collapse from fraught that it might lead to pulmonary ischemia or infection. It is unknown whether collapse of only the right lung is as effective as collapse of both lungs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aortic valve pathology requiring surgery.

Exclusion criteria

  • Prior thoracic surgery,
  • Severe chronic obstructive pulmonary disease and/or
  • Emphysema.

Treatment and study plan

Bilateral Open Pleurae

Procedure

Both pleurae are opened Right pulmonary vein drainage

Right Pleura Open

Procedure

Right pleura open Left ventricular apical drainage

Primary outcomes

  1. 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 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 the left middle cerebral artery will be reported.

  2. 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 on 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 the left middle cerebral artery will be reported.

  3. 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 the left middle cerebral artery will be reported.

  4. Number of 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 the aortic root, is assessed by Trans-esophageal Echocardiography (TEE) and classified in grade 0-3 as follows: Grade 0: no residual air emboli, Grade I: air emboli observed in one of three anatomic areas, Grade II: air emboli observed simultaneously in two of three anatomic areas, Grade III: air emboli observed simultaneously in all three anatomic areas.

  5. Number of 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 the aortic root, is assessed by Trans-esophageal Echocardiography (TEE) and classified in grade 0-3 as follows: Grade 0: no residual air emboli, Grade I: air emboli observed in one of three anatomic areas, Grade II: air emboli observed simultaneously in two of three anatomic areas, Grade III: air emboli observed simultaneously in all three anatomic areas.

  6. Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.

    Time frame: 7-10 minutes after finished de-airing

    The severity of residual air emboli in three anatomic areas; left atrium, left ventricle and the aortic root, is assessed by Trans-esophageal Echocardiography (TEE) and classified in grade 0-3 as follows: Grade 0: no residual air emboli, Grade I: air emboli observed in one of three anatomic areas, Grade II: air emboli observed simultaneously in two of three anatomic areas, Grade III: air emboli observed simultaneously in all three anatomic areas.

Secondary outcomes

  1. Duration of the De-airing Procedure

    Time frame: Duration in minutes fråm removal of the aortic cross clamp to finished de-airing, an average of 10-15 minutes.

    Duration of the de-airing procedure counted in minutes.

Sponsors and collaborators

Lead sponsor

Lund University

Other

Registry information

Official study title

Comparative Effectiveness of Unilateral Versus Bilateral Pulmonary Collapse in De-airing During Open Left Heart Surgery.

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 22, 2014
Registry last updated
Jan 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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