Mechanical Ventilation in Patients With Lung Impairment Controlled by the Mechanical Energy of the Respiratory System

Study Overview
=================
Brief Summary
-----------------
A project aimed at expanding the monitoring of mechanical energy (ME) in patients on mechanical ventilation (MV), with the aim of contributing to reducing the influence of the device for mechanical ventilation of patients on the lung parenchyma by setting parameters that will lead to lower ventilation energy. According to the parameters set on the device for mechanical ventilation, the mechanical energy will be calculated, which the physician in the interventional arm of the study will be able to use to change the mechanical ventilation settings. The physician will follow the best clinical practice, and in the non-intervention group, the MV setting will be conventional.

Detailed Description
-----------------
Mechanical ventilation (MV) in patients with acute respiratory failure (ARF) is one of the most common causes of hospitalization in the intensive care unit (ICU). ARF can be associated with severe forms of lung injury, the so-called ARDS (adult respiratory distress syndrome). Despite progress in the management of patients with ARDS, the mortality of these patients remains high, with in-hospital mortality reaching up to 45%. In patients with severe ARDS, mechanical ventilation can damage the lung parenchyma and cause ventilator-induced lung injury (VILI), which further worsens the patient's prognosis. The result of setting the individual parameters of mechanical ventilation is the energy that the device exerts on the lung parenchyma, which ensures the opening of the lungs and a change in their volume related to gas exchange during breathing. Routine laboratory values of blood gases and parameters of inflammation (CRP, PCT) will be recorded; which is part of routine clinical practice and standard patient care unrelated to the study. As part of a prospective randomized study, a system for monitoring mechanical energy at the patient's bedside will be developed. Patients will be randomized into two groups - the intervention arm (mechanical ventilation controlled according to ME) and the non-intervention arm (conventional method of conducting mechanical ventilation).

Official Title
-----------------
Protective Ventilation in Patients With Lung Impairment on Mechanical Ventilation Controlled by the Mechanical Energy of the Respiratory System

Conditions
-----------------
ARDS, Lung Injury, Ventilator Induced

Intervention / Treatment
-----------------
* Procedure: Mechanical energy monitoring
* Procedure: Conventional mechanical ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with fully controlled mechanical ventilation patients older than 18 years patients with lung disease (pneumonia, ARDS) expected duration of mechanical ventilation longer than 48 hours Exclusion Criteria: pregnant women, when this fact is stated in the admission protocol inclusion in the study in a period longer than 24 hours from the start of mechanical ventilation (from admission to the Anesthesiology and Resuscitation Department)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study subjects will be randomized into two parallel groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mechanical energy monitoring<br>In the study subjects randomized into this arm, the value of mechanical energy will be monitored during mechanical ventilation. | Procedure: Mechanical energy monitoring<br>* Monitoring of the mechanical energy acting on the lung parenchyma during mechanical ventilation.<br>|
| Active Comparator: Conventional mechanical ventilation<br>Study subjects randomized into this arm will receive conventional mechanical ventilation, to the best of the physician's knowledge. | Procedure: Conventional mechanical ventilation<br>* The conventional procedure of mechanical ventilation controlled according to the physician's decision.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of mechanical energy (in Joules/min) | The level of mechanical energy will be measured (in Joules/min) in both study arms. | up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of days on mechanical ventilation | The number of days on mechanical ventilation will be observed in both study arms. | up to 14 days | 
| The effect of mechanical energy on patient mortality | The effect of mechanical energy on patient mortality will be analysed in both study arms. A mortality rate is the number of deaths due to a disease divided by the total population. | up to 14 days | 
| The effect of mechanical energy on hospital mortality | The effect of mechanical energy on hospital mortality will be analysed in both study arms. A mortality rate is the number of deaths due to a disease divided by the total population. | up to 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mechanical ventilation, adult respiratory distress syndrome, ventilator-induced lung injury, mechanical energy