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

September 6, 2023 updated by: University Hospital Ostrava

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 70852
        • Recruiting
        • University Hospital Ostrava
        • Sub-Investigator:
          • Ondřej Jor, MD,PhD
        • Contact:
        • Principal Investigator:
          • Filip Burša, MD,PhD
        • Sub-Investigator:
          • Jan Máca, Assoc.Prof.,MD,PhD
        • Sub-Investigator:
          • Jan Štigler, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The level of mechanical energy (in Joules/min)
Time Frame: up to 14 days
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
Time Frame: up to 14 days
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
Time Frame: 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.
up to 14 days
The effect of mechanical energy on hospital mortality
Time Frame: 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.
up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Investigators

  • Principal Investigator: Filip Burša, MD,PhD, University Hospital Ostrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 15, 2023

First Submitted That Met QC Criteria

September 6, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25/RVO-FNOs/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data available to other researchers. The data may be provided upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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