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NCT Number: NCT01614951

The Pulmonary Protection Trial

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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Key information

Conditions

Chronic Obstructive Lung Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rigshospitalet

Copenhagen N, 2200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Perfusion of the lungs

Procedure

Pulmonary perfusion with oxygenated blood during ECC.

HTK Custodiol

Drug

Pulmoplegia before ECC.

Standard ECC

Other

ECC after standard procedure

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Lundbeck Foundation

Registry information

Official study title

Pulmonary Dysfunction After Open Heart Surgery: Randomized Clinical Trial With Focus on Lung-protective Interventions

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 8, 2012
Registry last updated
Apr 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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