EIT During FCV in the Intensive Care Unit

Electrical Impedance Tomography During Flow Controlled Ventilation 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.

Study Overview

• Status: Completed
• Conditions: Post-cardiac Surgery
• Intervention / Treatment: Device: Flow Controlled Ventilation (FCV)

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3015 GD
      • Erasmus Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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).

Device: Flow Controlled Ventilation (FCV); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
End-expiratory lung volume	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	Baseline EELV compared to after 30 minutes of FCV (same ventilator settings)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minute volume	The difference in minute volume between PCV and FCV with a stable PaCO2	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 and FCV are measured by using our own produced Pressure-Volume loops	The difference in Mechanical Power between PCV at baseline and after 90 minutes of FCV (after FCV optimization)
Dissipated energy	The difference in Dissipated energy between PCV and FCV are measured by using our own produced Pressure-Volume loops	The difference in Dissipated energy between PCV at baseline and after 90 minutes of FCV (after FCV optimization)

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Ventinova
• Investigators: Principal Investigator: Henrik Endeman, MD, PhD, Erasmus MC, Rotterdam

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2022
• Primary Completion (Actual): May 9, 2023
• Study Completion (Actual): May 9, 2023

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 9, 2022

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: ICU; Mechanical Power; FCV; EIT; Minute volume; Dissipated energy
• Other Study ID Numbers: NL 68962.078.19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No