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Clinical Trials/NCT06189924
NCT06189924RecruitingNot Applicable

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

The Institute of Molecular and Translational Medicine, Czech Republic2 sites in 1 country200 target enrollmentStarted: March 1, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
200
Locations
2
Primary Endpoint
Comparison of proteomic patterns of the exhaled breath condensate in mechanically ventilated intensive care patients.

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Mechanically ventilated patients with primary or secondary lung injury

Mechanically ventilated patients with primary or secondary lung injury due to various pathologies. Patients will be treated at intensive care units (ICU).

Intervention: Proteomic analysis of exhaled breath condensate (Diagnostic Test)

Mechanically ventilated patients without lung injury

Mechanically ventilated patients without lung injury, with various pathologies. Patients will be treated at intensive care units (ICU).

Intervention: Proteomic analysis of exhaled breath condensate (Diagnostic Test)

Outcomes

Primary Outcomes

Comparison of proteomic patterns of the exhaled breath condensate in mechanically ventilated intensive care patients.

Time Frame: January 2024 - December 2029

Proteomic patterns of the exhaled breath condensate will be studied in mechanically ventilated intensive care patients. The results will be analysed and compared with the aim to identify patterns specific for the pathological conditions.

Secondary Outcomes

  • Correlation of exhaled breath condensate patterns with molecular biological findings in venous blood - proteins(January 2024 - December 2029)
  • Correlation of exhaled breath condensate patterns with molecular biological findings in venous blood - DNA(January 2024 - December 2029)
  • Correlation of exhaled breath condensate patterns with molecular biological findings in venous blood - RNA(January 2024 - December 2029)
  • Correlation of exhaled breath condensate patterns with molecular biological findings in venous blood - metabolites(January 2024 - December 2029)

Investigators

Sponsor
The Institute of Molecular and Translational Medicine, Czech Republic
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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