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

University Hospital Ostrava

Status: Enrolling

Conditions: Lung Injury, Ventilator Induced; ARDS

Treatments: Procedure: Mechanical energy monitoring; Procedure: Conventional mechanical ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT06035146

25/RVO-FNOs/2022

Details and patient eligibility

About

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.

Full 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).

Enrollment: 34 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Mechanical energy monitoring

Experimental group

Description:

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

Treatment:

Procedure: Mechanical energy monitoring

Conventional mechanical ventilation

Active Comparator group

Description:

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

Treatment:

Procedure: Conventional mechanical ventilation