Clinical trial NCT05644418: EIT During FCV in the Intensive Care Unit
Official title: Electrical Impedance Tomography During Flow Controlled Ventilation in the Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-cardiac Surgery
Keywords: FCV
EIT
Mechanical Power
Minute volume
Dissipated energy
ICU
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Ventinova
First posted: 2022-12-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: PCV at baseline, followed by 90 minutes of FCV and finished with 30 minutes of PCV
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: End-expiratory lung volume
timeFrame: Baseline EELV compared to after 30 minutes of FCV (same ventilator settings)
Secondary outcomes:
measure: Minute volume
timeFrame: The difference in minute volume between PCV at baseline and after 90 minutes of FCV (after optimization of FCV)
measure: Mechanical Power
timeFrame: The difference in Mechanical Power between PCV at baseline and after 90 minutes of FCV (after FCV optimization)
measure: Dissipated energy
timeFrame: The difference in Dissipated energy between PCV at baseline and after 90 minutes of FCV (after FCV optimization)
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid-Holland
Study officials:
affiliation: Erasmus MC, Rotterdam
name: Henrik Endeman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: