The Pulmonary Protection Trial
Summary
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).
Timeline
- Start
- 2012-07
- Primary completion
- 2013-11
- Completion
- 2013-11
Outcome
Mixed primary results
paper The coprimary outcomes were the inverse oxygenation index compared at 21 hours after starting CPB and longitudinally in a mixed-effects model (MEM). PMID 27651908 ↗
paper had a higher oxygenation index compared with no pulmonary perfusion (mean difference (MD) 0.94; 95% CI 0.05 to 1.83; p=0.04). PMID 27651908 ↗
paper Yet the blood or HTK groups did not demonstrate a longitudinally higher oxygenation index compared with no pulmonary perfusion (MEM, p=0.57 and 0.17). PMID 27651908 ↗
paper no difference in the oxygenation index between the HTK group and those no pulmonary perfusion (MD 0.06; 95% CI -0.73 to 0.86; p=0.87). PMID 27651908 ↗
Publications
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HTK Custodiol | Unknown | — | — |