EIT During FCV in the Intensive Care Unit

NCT05644418 | Completed

• 1 other identifier: NL 68962.078.19
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-cardiac Surgery

Keywords

FCV; EIT; Mechanical Power; Minute volume; Dissipated energy; ICU

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

• Dissipated energy

  The difference in Dissipated energy between PCV at baseline and after 90 minutes of FCV (after FCV optimization)

Study Arms (1)

Postcardiac surgery ICU-patients

EXPERIMENTAL

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)

Interventions

Flow Controlled Ventilation (FCV) DEVICE

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.

Postcardiac surgery ICU-patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Ventinova: collaborator

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Related Publications (1)

• Van Oosten JP, Francovich JE, Somhorst P, van der Zee P, Endeman H, Gommers DAMPJ, Jonkman AH. Flow-controlled ventilation decreases mechanical power in postoperative ICU patients. Intensive Care Med Exp. 2024 Mar 19;12(1):30. doi: 10.1186/s40635-024-00616-9.

  PMID: 38502268 DERIVED

Study Officials

• Henrik Endeman, MD, PhD

  Erasmus MC, Rotterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: H. Endeman, MD, PhD, Principle Investigator

Model Details: PCV at baseline, followed by 90 minutes of FCV and finished with 30 minutes of PCV

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 9, 2022
• Study Start: February 22, 2022
• Primary Completion: May 9, 2023
• Study Completion: May 9, 2023
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)