Pulmonary Dysfunction After Open Heart Surgery: Randomized Clinical Trial With Focus on Lung-protective Interventions
Overview
- Phase
- Phase 4
- Intervention
- Perfusion of the lungs
- Conditions
- Chronic Obstructive Lung Disease
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Oxygenation Index
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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).
Investigators
Daniel Steinbruchel
Prof. dr. med.
Rigshospitalet, Denmark
Eligibility Criteria
Inclusion Criteria
- •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
- •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
Arms & Interventions
Pulmonary perfusion
Intervention: Perfusion of the lungs
Pulmoplegia
Intervention: HTK Custodiol
Control group
Intervention: Standard ECC
Outcomes
Primary Outcomes
Oxygenation Index
Time Frame: 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).