The Pulmonary Protection Trial

Conditions

Chronic Obstructive Lung Disease

Brief 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).

Emilie C. Risom, Katrine B. Buggeskov, Ulla B. Mogensen, Martin Sundskard, Jann Mortensen et al. (6 authors)

Interactive Cardiovascular and Thoracic Surgery2019-02-1815 citations

10.1093/icvts/ivz049

Pulmonary artery perfusion versus no pulmonary perfusion during cardiopulmonary bypass in patients with COPD: a randomised clinical trial

Katrine B. Buggeskov, Martin Sundskard, Thomas E. N. Jonassen, Lars W. Andersen, Niels H. Secher et al. (9 authors)

BMJ Open Respiratory Research2016-09-0115 citations

10.1136/bmjresp-2016-000146

Detailed statistical analysis plan for the pulmonary protection trial.

Buggeskov KB, Jakobsen JC, Secher NH, Jonassen T, Andersen LW, Steinbrüchel DA, Wetterslev J.

2014-12-231 citations

10.1186/1745-6215-15-510

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.

Buggeskov KB, Wetterslev J, Secher NH, Andersen LW, Jonassen T, Steinbrüchel DA.

2013-01-318 citations

10.1186/1745-6215-14-30

Interventions

PROCEDUREPerfusion of the lungs

Pulmonary perfusion with oxygenated blood during ECC.

DRUGHTK Custodiol

Pulmoplegia before ECC.

OTHERStandard ECC

ECC after standard procedure

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

1. Planned and urgent surgery on legally competent patients over 18 years: * Coronary Artery Bypass Graft Surgery * Aortic Valve Replacement * Coronary Artery Bypass Graft Surgery + Aortic Valve Replacement * Transcatheter Aortic-Valve Implantation 2. 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

* Previous surgery on the heart or lungs * Previous thoracic irradiation * Preoperative heart failure (ejection fraction below 20%). * Surgical demanding mitral regurgitation * Unstable patients (heart rate above 100 and systolic blood pressure below 100 mmHg) * Intubated patients * Patients with an ongoing preoperative treatment with antibiotics for suspected pneumonia. * Patients with renal insufficiency requiring hemodialysis * Pregnant and lactating

Design outcomes

Primary

Measure	Time frame	Description
Oxygenation Index	From pre operation until 24 hours post operation	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).

Countries

Denmark

Outcome results

None listed