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

Sponsor

University Hospital Ostrava (Other)

Overall Status

Recruiting

CT.gov ID

NCT06035146

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ARDS Lung Injury, Ventilator Induced	Procedure: Mechanical energy monitoring Procedure: Conventional mechanical ventilation	N/A

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The study subjects will be randomized into two parallel groups.The study subjects will be randomized into two parallel groups.

Masking:

None (Open Label)

Masking Description:

No masking will be used in the study.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jul 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Mechanical energy monitoring

In the study subjects randomized into this arm, the value of mechanical energy will be monitored during mechanical ventilation.

Procedure: Mechanical energy monitoring

Monitoring of the mechanical energy acting on the lung parenchyma during mechanical ventilation.

Active Comparator: Conventional mechanical ventilation

Study subjects randomized into this arm will receive conventional mechanical ventilation, to the best of the physician's knowledge.

Procedure: Conventional mechanical ventilation

The conventional procedure of mechanical ventilation controlled according to the physician's decision.

Outcome Measures

Primary Outcome Measures

The level of mechanical energy (in Joules/min) [up to 14 days]
The level of mechanical energy will be measured (in Joules/min) in both study arms.

Secondary Outcome Measures

The number of days on mechanical ventilation [up to 14 days]
The number of days on mechanical ventilation will be observed in both study arms.
The effect of mechanical energy on patient mortality [up to 14 days]
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.
The effect of mechanical energy on hospital mortality [up to 8 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)