The Pulmonary Protection Trial

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Collaborator: Lundbeck Foundation

Criteria

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