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

Primary Purpose

ARDS, Lung Injury, Ventilator Induced

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Mechanical energy monitoring
Conventional mechanical ventilation
Sponsored by
University Hospital Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ARDS focused on measuring mechanical ventilation, adult respiratory distress syndrome, ventilator-induced lung injury, mechanical energy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • University Hospital OstravaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mechanical energy monitoring

Conventional mechanical ventilation

Arm Description

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

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

Outcomes

Primary Outcome Measures

The level of mechanical energy (in Joules/min)
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
The number of days on mechanical ventilation will be observed in both study arms.
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.
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.

Full Information

First Posted
February 15, 2023
Last Updated
September 6, 2023
Sponsor
University Hospital Ostrava
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1. Study Identification

Unique Protocol Identification Number
NCT06035146
Brief Title
Mechanical Ventilation in Patients With Lung Impairment Controlled by the Mechanical Energy of the Respiratory System
Official Title
Protective Ventilation in Patients With Lung Impairment on Mechanical Ventilation Controlled by the Mechanical Energy of the Respiratory System
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS, Lung Injury, Ventilator Induced
Keywords
mechanical ventilation, adult respiratory distress syndrome, ventilator-induced lung injury, mechanical energy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study subjects will be randomized into two parallel groups.
Masking
None (Open Label)
Masking Description
No masking will be used in the study.
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mechanical energy monitoring
Arm Type
Experimental
Arm Description
In the study subjects randomized into this arm, the value of mechanical energy will be monitored during mechanical ventilation.
Arm Title
Conventional mechanical ventilation
Arm Type
Active Comparator
Arm Description
Study subjects randomized into this arm will receive conventional mechanical ventilation, to the best of the physician's knowledge.
Intervention Type
Procedure
Intervention Name(s)
Mechanical energy monitoring
Intervention Description
Monitoring of the mechanical energy acting on the lung parenchyma during mechanical ventilation.
Intervention Type
Procedure
Intervention Name(s)
Conventional mechanical ventilation
Intervention Description
The conventional procedure of mechanical ventilation controlled according to the physician's decision.
Primary Outcome Measure Information:
Title
The level of mechanical energy (in Joules/min)
Description
The level of mechanical energy will be measured (in Joules/min) in both study arms.
Time Frame
up to 14 days
Secondary Outcome Measure Information:
Title
The number of days on mechanical ventilation
Description
The number of days on mechanical ventilation will be observed in both study arms.
Time Frame
up to 14 days
Title
The effect of mechanical energy on patient mortality
Description
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.
Time Frame
up to 14 days
Title
The effect of mechanical energy on hospital mortality
Description
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.
Time Frame
up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiří Hynčica
Phone
0042059737
Ext
2587
Email
jiri.hyncica@fno.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filip Burša, MD,PhD
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
70852
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiří Hynčica
Phone
0042059737
Ext
258'7
Email
jiri.hyncica@fno.cz
First Name & Middle Initial & Last Name & Degree
Filip Burša, MD,PhD
First Name & Middle Initial & Last Name & Degree
Jan Máca, Assoc.Prof.,MD,PhD
First Name & Middle Initial & Last Name & Degree
Ondřej Jor, MD,PhD
First Name & Middle Initial & Last Name & Degree
Jan Štigler, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
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Mechanical Ventilation in Patients With Lung Impairment Controlled by the Mechanical Energy of the Respiratory System

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