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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-006290-25 | EudraCT Number | ||
| 4141 | Other Identifier | EudraCT Protocol kode | |
| H-1-2012-0 24 | Other Identifier | The Danish Scientific Ethical Committee protocol code | |
| 2007-58-0015. | Other Identifier | The Danish Data Protection Agency journal number |
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| Name | Class |
|---|---|
| Lundbeck Foundation | OTHER |
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The purpose of this study is to investigate whether patients with a preoperative reduced pulmonary function have a better preserved oxygenation capacity after open heart surgery, using either pulmonary perfusion or pulmoplegia compared with TAVI and the control-group with standard ECC (Extra Corporal Circulation).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary perfusion | Experimental |
| |
| Pulmoplegia | Experimental |
| |
| Control group | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perfusion of the lungs | Procedure | Pulmonary perfusion with oxygenated blood during ECC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oxygenation Index | To investigate whether patients with a preoperative reduced pulmonary function have a better preserved oxygenation index after open heart surgery, using either pulmonary perfusion or pulmoplegia compared with TAVI and the control-group with standard ECC (Extra Corporal Circulation). | From pre operation until 24 hours post operation |
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Inclusion Criteria:
Planned and urgent surgery on legally competent patients over 18 years:
Spirometry FEV1 measurement show less than or equal to 80% of the anticipated. We expect that these patients provide the largest signal with lung protective interventions in relation to lung healthy patients.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel A. Steinbrüchel, prof. | Rigshospitalet, Thoracic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen N | 2200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30879046 | Derived | Risom EC, Buggeskov KB, Mogensen UB, Sundskard M, Mortensen J, Ravn HB. Preoperative pulmonary function in all comers for cardiac surgery predicts mortalitydagger. Interact Cardiovasc Thorac Surg. 2019 Aug 1;29(2):244-251. doi: 10.1093/icvts/ivz049. Epub 2019 Mar 15. | |
| 27651908 | Derived | Buggeskov KB, Sundskard MM, Jonassen T, Andersen LW, Secher NH, Ravn HB, Steinbruchel DA, Jakobsen JC, Wetterslev J. Pulmonary artery perfusion versus no pulmonary perfusion during cardiopulmonary bypass in patients with COPD: a randomised clinical trial. BMJ Open Respir Res. 2016 Sep 6;3(1):e000146. doi: 10.1136/bmjresp-2016-000146. eCollection 2016. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C039984 | Bretschneider cardioplegic solution |
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| HTK Custodiol | Drug | Pulmoplegia before ECC. |
|
| Standard ECC | Other | ECC after standard procedure |
|
| 25539792 | Derived | Buggeskov KB, Jakobsen JC, Secher NH, Jonassen T, Andersen LW, Steinbruchel DA, Wetterslev J. Detailed statistical analysis plan for the pulmonary protection trial. Trials. 2014 Dec 23;15:510. doi: 10.1186/1745-6215-15-510. |
| 23363494 | Derived | Buggeskov KB, Wetterslev J, Secher NH, Andersen LW, Jonassen T, Steinbruchel DA. Pulmonary perfusion with oxygenated blood or custodiol HTK solution during cardiac surgery for postoperative pulmonary function in COPD patients: a trial protocol for the randomized, clinical, parallel group, assessor and data analyst blinded Pulmonary Protection Trial. Trials. 2013 Jan 31;14:30. doi: 10.1186/1745-6215-14-30. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |