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Flow Controlled Ventilation in Cardiac Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04306757
Enrollment
54
Registered
2020-03-13
Start date
2020-03-06
Completion date
2021-03-02
Last updated
2021-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Positive-Pressure Respiration, Respiration; Artificial

Keywords

flow controlled ventilation, pressure controlled ventilation, cardiac surgery

Brief summary

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.

Detailed description

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.

Interventions

DEVICEEvone

Airway ventilation device

DEVICEPrimus

Airway ventilation device

Sponsors

Medical University Innsbruck
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

controlled, prospective

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Horowitz Index15 minutes after chest closurearterial partial pressure of Oxygen (paO2) / fraction of inspired Oxygen (FiO2)

Secondary

MeasureTime frameDescription
lung tissue aerationimmediately postoperativeLung tissue aeration assessed by Hounsfield units analysis of computed tomography

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026