EIT During FCV in the Intensive Care Unit

Not Applicable

Completed

• Conditions: Post-cardiac Surgery

• Registration Number: NCT05644418
• Lead Sponsor: Erasmus Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-22
• Study First Submitted: 2022-12-01
• Study First Submitted QC: 2022-12-01
• Study First Posted: 2022-12-09
• Primary Completion: 2023-05-09
• Study Completion: 2023-05-09
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
End-expiratory lung volume	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 Outcome Measures

Name	Time	Method
Dissipated energy	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
Minute volume	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
Mechanical Power	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

Trial Locations

Locations (1)

Erasmus Medical Center; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands