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Completed

NCT Number: NCT05644418

EIT During FCV in the Intensive Care Unit

The goal of this clinical trial is to study the effects of Flow Controlled Ventilation (FCV) following conventional mechanical ventilation (Pressure or Volume Controlled Ventilation) in postcardiac surgery ICU-patients to allow for future power calculations and to obtain experience with FCV.

The main questions it aims to answer are:

* What is the effect of FCV on the lung volume measured by Electrical Impedance Tomography (EIT)? * What is the effect of FCV on the minute volume? * What is the effect of FCV on the mechanical power and dissipated energy?

Participants will be ventilated with PCV at baseline and then switched to FCV for 90 minutes while the lung volume, minute volume and mechanical power and dissipated energy levels are measured.

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Key information

Conditions

Post-cardiac Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasmus Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years or older;
  • Informed consent form signed by the subject or a legal representative;
  • Controlled mechanical ventilation via an endotracheal tube -
  • FiO2 ≤50% and PEEP 10 cmH2O or lower

Exclusion criteria

  • Severe sputum stasis or production requiring frequent bronchial suctioning (more than 5 times per nurse shift)
  • Severe respiratory insufficiency defined as a PaO2 to FiO2 ratio of <100mmHg or moderate to severe ARDS according to the Berlin definition of ARDS
  • Untreated pneumothorax (i.e. no pleural drainage)
  • Hemodynamic instability defined as a mean arterial pressure below 60mmHg not responding to fluids and/or vasopressors or a noradrenalin dose >0.4mg/kg/min
  • Excessive subcutaneous emphysema (prevents proper functioning of the EIT device)
  • Thoracic wounds, bandages or other obstruction which prevent proper functioning of the EIT device
  • High (>15 mmHg) or instable (an increase in sedation or osmotherapy is required) intracranial pressure
  • An inner tube diameter of 6mm or less

Treatment and study plan

Flow Controlled Ventilation (FCV)

Device

FCV is started with the same settings as PCV (PEEP, Ppeak, FiO2) and after 30 minutes FCV is optimized concerning the driving pressure and PEEP using the dynamic compliance. After a total of 60 minutes the flow is adjusted based on the arterial blood gas.

Primary outcomes

  1. End-expiratory lung volume

    Time frame: Baseline EELV compared to after 30 minutes of FCV (same ventilator settings)

    The difference in End-expiratory lung volume (EELV) between PCV and FCV is measured using the difference in End-expiratory lung impedance (EELI) and tidal volume at baseline

Secondary outcomes

  1. Minute volume

    Time frame: The difference in minute volume between PCV at baseline and after 90 minutes of FCV (after optimization of FCV)

    The difference in minute volume between PCV and FCV with a stable PaCO2

  2. Mechanical Power

    Time frame: The difference in Mechanical Power between PCV at baseline and after 90 minutes of FCV (after FCV optimization)

    The difference in Mechanical Power between PCV and FCV are measured by using our own produced Pressure-Volume loops

  3. Dissipated energy

    Time frame: The difference in Dissipated energy between PCV at baseline and after 90 minutes of FCV (after FCV optimization)

    The difference in Dissipated energy between PCV and FCV are measured by using our own produced Pressure-Volume loops

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Ventinova

Registry information

Official study title

Electrical Impedance Tomography During Flow Controlled Ventilation in the Intensive Care Unit

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 9, 2022
Registry last updated
Jan 12, 2024

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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