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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05644418
Other study ID # NL 68962.078.19
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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