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Trial record 2 of 591 for:    flow controlled ventilation

Flow Controlled Ventilation in Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT04306757
Recruitment Status : Completed
First Posted : March 13, 2020
Last Update Posted : March 23, 2021
Sponsor:
Information provided by (Responsible Party):
Medical University Innsbruck

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.

Condition or disease Intervention/treatment Phase
Respiration; Artificial Positive-Pressure Respiration Device: Evone Device: Primus Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: controlled, prospective
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Flow Controlled Ventilation Versus Pressure Controlled Ventilation in Cardiac Surgery After Cardiopulmonary Bypass Without Ventilation - a Prospective, Randomized Clinical Study
Actual Study Start Date : March 6, 2020
Actual Primary Completion Date : March 2, 2021
Actual Study Completion Date : March 2, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Experimental: FCV
Artificial ventilation will be performed with individualized flow-controlled ventilation (Evone, Ventinova Medical B.V., Eindhoven, the Netherlands) during cardiac surgery until admission to postoperative ICU. Individualisation will be established by compliance guided end-expiratory and peak pressure setting, flow setting will be adjusted to secure normocapnia and I:E Ratio set to 1:1.
Device: Evone
Airway ventilation device

Active Comparator: PCV
Artificial ventilation will be performed with low tidal volume pressure-controlled ventilation (Primus, Dräger, Lübeck, Germany) during cardiac surgery until admission to postoperative ICU. Peak pressure will be set to achieve a tidal volume of 7ml/kg predicted body weight at a compliance titrated positive end-expiratory pressure. Respiratory rate will be set to maintain normocapnia and I:E ratio set to 1:1.5 except extension of expiration is necessary in order to avoid air trapping.
Device: Primus
Airway ventilation device




Primary Outcome Measures :
  1. Horowitz Index [ Time Frame: 15 minutes after chest closure ]
    arterial partial pressure of Oxygen (paO2) / fraction of inspired Oxygen (FiO2)


Secondary Outcome Measures :
  1. lung tissue aeration [ Time Frame: immediately postoperative ]
    Lung tissue aeration assessed by Hounsfield units analysis of computed tomography



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04306757


Locations
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Austria
Medical University Innsbruck
Innsbruck, Tyrol, Austria, 6020
Sponsors and Collaborators
Medical University Innsbruck
Investigators
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Principal Investigator: Judith Martini, MD Medical University Innsbruck, Dept. of Anaesthesiology
Publications:
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Responsible Party: Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT04306757    
Other Study ID Numbers: 1211/2019
First Posted: March 13, 2020    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University Innsbruck:
flow controlled ventilation
pressure controlled ventilation
cardiac surgery