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

L

Lund University

Status

Completed

Conditions

Brain Ischemia
Reduction of Cerebral Air Emboli

Treatments

Procedure: Bilateral Open Pleurae
Procedure: Right Pleura Open

Study type

Interventional

Funder types

Other

Identifiers

NCT02119871
BKML-004

Details and patient eligibility

About

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

Full description

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.

Enrollment

20 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Aortic valve pathology requiring surgery.

Exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

20 participants in 2 patient groups

Bilateral Open Pleurae
Experimental group
Description:
Bilateral open pleurae and usage of right pulmonary vein drainage
Treatment:
Procedure: Bilateral Open Pleurae
Right pleura open
Active Comparator group
Description:
Opening of right pleura and usage of left ventricular apical drainage.
Treatment:
Procedure: Right Pleura Open

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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