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

NCT02119871 | Completed Results

• 1 other identifier: BKML-004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Brain Ischemia; Reduction of Cerebral Air Emboli

Keywords

Cerebral air emboli, heart surgery

Outcome Measures

Primary Outcomes (6)

• 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 the left middle cerebral artery will be reported.

  Time from the release of the aortic crossclamp to cardiac ejection, 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 the left middle cerebral artery will be reported.

  Time from cardiac ejection to finished de-airing, an average on 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 the left middle cerebral artery will be reported.

  Period of ten minutes after finished de-airing

• Number of 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 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.

  0-3 minutes after finished de-airing

• Number of 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 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.

  3-6 minutes after finished de-airing

• Number of 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 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.

  7-10 minutes after finished de-airing

Secondary Outcomes (1)

• Duration of the De-airing Procedure

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

Study Arms (2)

Bilateral Open Pleurae

EXPERIMENTAL

Bilateral open pleurae and usage of right pulmonary vein drainage

Procedure: Bilateral Open Pleurae

Right pleura open

ACTIVE COMPARATOR

Opening of right pleura and usage of left ventricular apical drainage.

Procedure: Right Pleura Open

Interventions

Bilateral Open Pleurae PROCEDURE

Both pleurae are opened Right pulmonary vein drainage

Bilateral Open Pleurae

Right Pleura Open PROCEDURE

Right pleura open Left ventricular apical drainage

Right pleura open

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aortic valve pathology requiring surgery.

You may not qualify if:

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

Sponsors & Collaborators

• Lund University: lead

Study Sites (1)

Department of Cardiothoracic Department, Skane University Hospital

Lund, Lund, Skåne, 221 85, Sweden

Location

MeSH Terms

Conditions

Brain Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Maya Landenhed Smith
• Organization: Department of Cardiothoracic Surgery, Lund University

maya.landenhed_smith@med.lu.se

+4646173639

Study Officials

• Bansi Koul, MD, PhD

  Lund University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lund University

Study Record Dates

• First Submitted: April 17, 2014
• First Posted: April 22, 2014
• Study Start: January 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 29, 2018
• Results First Posted: January 29, 2018

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)