EIT During FCV in the Intensive Care Unit

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-22

Study Completion Date

2023-05-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Post-cardiac Surgery

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

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

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Flow Controlled Ventilation (FCV)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No