The Pulmonary Protection Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-11-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Chronic Obstructive Lung Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Pulmonary perfusion

Group Type EXPERIMENTAL

Perfusion of the lungs

Intervention Type PROCEDURE

Pulmonary perfusion with oxygenated blood during ECC.

Pulmoplegia

Group Type EXPERIMENTAL

HTK Custodiol

Intervention Type DRUG

Pulmoplegia before ECC.

Control group

Group Type OTHER

Standard ECC

Intervention Type OTHER

ECC after standard procedure

Interventions

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Perfusion of the lungs

Pulmonary perfusion with oxygenated blood during ECC.

Intervention Type PROCEDURE

HTK Custodiol

Pulmoplegia before ECC.

Intervention Type DRUG

Standard ECC

ECC after standard procedure

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No