Electrical Impedance Tomography During Flow Controlled Ventilation in the Intensive Care Unit
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Erasmus Medical Center
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- End-expiratory lung volume
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Postcardiac surgery ICU-patients
After postcardiac surgery patients are brought to the ICU and are ventilated on PCV (Pressure Controlled Ventilation). Measurements of the lung volume (by Electrical Impedance Tomography; EIT), the minute volume and Mechanical Power/Dissipated energy are started and continued for the duration of the study. After a few minutes the patient is switched to FCV (Flow Controlled Ventilation) for 90 minutes and afterwards PCV is resumed with the measurements lasting for another 30 minutes (total study time 120 minutes).
Intervention: Flow Controlled Ventilation (FCV) (Device)
Outcomes
Primary Outcomes
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
- Dissipated energy(The difference in Dissipated energy between PCV at baseline and after 90 minutes of FCV (after FCV optimization))
- Minute volume(The difference in minute volume between PCV at baseline and after 90 minutes of FCV (after optimization of FCV))
- Mechanical Power(The difference in Mechanical Power between PCV at baseline and after 90 minutes of FCV (after FCV optimization))
Investigators
Henrik Endeman
H. Endeman, MD, PhD, Principle Investigator
Erasmus Medical Center