The Pulmonary Protection Trial

Rigshospitalet, Denmark90 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Chronic Obstructive Lung Disease

Interventions

Perfusion of the lungsPROCEDURE

Pulmonary perfusion with oxygenated blood during ECC.

HTK CustodiolDRUG

Pulmoplegia before ECC.

Standard ECCOTHER

ECC after standard procedure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Rigshospitalet

Copenhagen N, Denmark

Outcomes

Primary Outcomes

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).

Time frame: From pre operation until 24 hours post operation

Data from ClinicalTrials.gov

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