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Recruiting NCT06189924

Exhaled Breath Condensate Analysis in Mechanically Ventilated Patients

Observational Acute Respiratory Failure Critical Illness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Proteomic analysis of exhaled breath condensate.
Who it may be relevant to
Registry conditions: Acute Respiratory Failure, Critical Illness. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Proteomic Analysis of Exhaled Breath Condensate in Mechanically Ventilated Intensive Care Patients

Overview

Mechanically ventilated intensive care patients will be sampled for a small amount of exhaled breath condensate from the ventilator circuit and for venous blood. Proteomic analysis of the exhaled breath condensate will be performed using mass spectrometry and in the blood sample, corresponding changes in the DNA, RNA, proteins, and metabolites will be studied. Resulting profiles will be correlated with routinely monitored parameters in order to identify patterns corresponding to various pathologies in order to enable their early detection.

Detailed description

Exhaled breath condensate (EBC) is a product of gas exchange in the lungs. It contains plethora of substances of possible diagnostic value and its composition is likely to change rapidly in response to the development of pathological conditions, especially in the lungs.

Mechanically ventilated intensive care patients with various pathological conditions will be sampled for a small amount of EBC from the ventilator circuit and for venous blood. A sampling method not affecting relevant parameters of mechanical ventilation will be developed and standardised.

EBC samples will be frozen and after processing, proteomic analyses will be performed using mass spectrometry. In the blood sample, corresponding changes in the DNA, RNA, proteins, and metabolites will be studied using molecular biological methods. Resulting profiles will be correlated with routinely monitored parameters (such as inflammation markers, microbiological findings and mechanical ventilation parameters) with the aim of finding patterns corresponding to the early stages of various pathological conditions focusing on lung tissue. Identification of patterns specific to initial stages of lung and other organ pathologies would enable their early treatment possibly shortening mechanical ventilation/ICU stay and reducing morbidity/mortality.

Interventions

  • Diagnostic test Proteomic analysis of exhaled breath condensate
    Mechanically ventilated intensive care patients will be sampled for exhaled breath condensate from the ventilator circuit.

Primary outcome measures

  • Comparison of proteomic patterns of the exhaled breath condensate in mechanically ventilated intensive care patients. [Time frame: January 2024 - December 2029]
Secondary outcome measures (4)
  • Correlation of exhaled breath condensate patterns with molecular biological findings in venous blood - DNA [Time frame: January 2024 - December 2029]
  • Correlation of exhaled breath condensate patterns with molecular biological findings in venous blood - RNA [Time frame: January 2024 - December 2029]
  • Correlation of exhaled breath condensate patterns with molecular biological findings in venous blood - proteins [Time frame: January 2024 - December 2029]
  • Correlation of exhaled breath condensate patterns with molecular biological findings in venous blood - metabolites [Time frame: January 2024 - December 2029]

Eligibility criteria

Inclusion criteria

Intensive care setting Mechanical ventilation Ventilator/ventilator circuit technically suitable for sampling of exhaled breath condensate

Exclusion criteria

Mechanical ventilation challenging to the extent that the insertion of the sampling kit into the ventilator circuit would substantially increase the risk for respiratory deterioration

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Czechia · 2 centers
  • Institute of Molecular and Translational Medicine, Palacky University — Olomouc
  • University Hospital Olomouc — Olomouc

Identifiers

NCT: NCT06189924 · 64734

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗