EIT During FCV in the Intensive Care Unit

Post-cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05644418
• Other study ID #: NL 68962.078.19
• Status: Completed
• Phase: N/A
• Start date: February 22, 2022
• Est. completion date: May 9, 2023

Study information

• Verified date: January 2024
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 9, 2023
• Est. primary completion date: May 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post-cardiac Surgery

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center	Rotterdam	Zuid-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Erasmus Medical Center	Ventinova

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)