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Completed

NCT Number: NCT04306757

Flow Controlled Ventilation in Cardiac Surgery

This trial investigates effects of individualized (by compliance guided pressure settings) flow-controlled ventilation compared to best clinical practice pressure controlled ventilation in cardiac surgery requiring cardiopulmonary bypass.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

About this study

The aim of the study is to investigate flow-controlled ventilation (FCV) during cardiac surgery requiring cardiopulmonary bypass. Previous preclinical trials have already shown improved oxygenation and CO2 removal within a significantly reduced respiratory minute volume as an expression of more efficient gas exchange with FCV compared to volume controlled ventilation (VCV). Preliminary data of our own animal study comparing individualized FCV by compliance guided pressure settings with state-of-the-art low tidal volume pressure controlled ventilation (PCV) confirmed previous findings with a significantly improved oxygenation by 20% while reducing respiratory minute volume. We therefore assume that FCV may be a more lung protective ventilation method.

Open heart surgery requires bridging of the heart and lung function with a cardiopulmonary bypass (CPB) performed by a heart-lung machine. During this time the lung is most frequently not ventilated at all and lies collapsed in the chest for several hours. After weaning from CPB, the lungs must be recruited and ensure sufficient gas exchange of the blood. Not surprisingly, the incidence of postoperative pulmonary complications (PPC) at 20-30% is comparatively high after cardiac surgery and is the leading cause of perioperative mortality. Based on previous trials we expect improved oxygenation and thus arterial partial pressure of oxygen (pO2) is the main primary outcome parameter of this study. Furthermore, we expect improved recruitment of lung tissue due to controlled expiratory flow in FCV without the need of recruitment maneuvers, which may cause deleterious effects on lung tissue. Thus, lung tissue aeration assessed by Hounsfield units analyses of a postoperative computed tomography will be a secondary outcome parameter.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female subjects >18 years
  • Body weight >40 kg
  • Elective cardiac surgery with CPB and without ventilation during CPB
  • American Society of Anaesthesiologists (ASA) risc classification I-IV
  • Written informed consent

Exclusion criteria

  • Emergency surgery
  • Female subjects known to be pregnant
  • Known participation in another interventional clinical trial
  • High risk cardiac surgery such as double valve surgery, re-cardiac surgery, intraoperative cardiac arrest or pre-existing high grade cardiomyopathy (ejection fraction <30%)
  • Closing operation field without chest closure due to hemodynamic instability
  • Acute endocarditis under antibiotic treatment
  • Minimal invasive valve surgery via thoracotomy (MIC)

Treatment and study plan

Evone

Device

Airway ventilation device

PRIMUS

Device

Airway ventilation device

Primary outcomes

  1. Horowitz Index

    Time frame: 15 minutes after chest closure

    arterial partial pressure of Oxygen (paO2) / fraction of inspired Oxygen (FiO2)

Secondary outcomes

  1. lung tissue aeration

    Time frame: immediately postoperative

    Lung tissue aeration assessed by Hounsfield units analysis of computed tomography

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Official study title

Flow Controlled Ventilation Versus Pressure Controlled Ventilation in Cardiac Surgery After Cardiopulmonary Bypass Without Ventilation - a Prospective, Randomized Clinical Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 13, 2020
Registry last updated
Mar 23, 2021

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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