Clinical trial NCT06189924: Exhaled Breath Condensate Analysis in Mechanically Ventilated Patients
Official title: Proteomic Analysis of Exhaled Breath Condensate in Mechanically Ventilated Intensive Care Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Respiratory Failure
Critical Illness
Keywords: exhaled breath condensate
proteomics
genomics
mechanical ventilation
acute respiratory failure
lung injury
intensive care
Lead sponsor: The Institute of Molecular and Translational Medicine, Czech Republic
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mechanically ventilated intensive care patients with or without acute hypoxemic respiratory failure

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.

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

Primary outcomes:
measure: Comparison of proteomic patterns of the exhaled breath condensate in mechanically ventilated intensive care patients.
timeFrame: January 2024 - December 2029
Secondary outcomes:
measure: Correlation of exhaled breath condensate patterns with molecular biological findings in venous blood - DNA
timeFrame: January 2024 - December 2029
measure: Correlation of exhaled breath condensate patterns with molecular biological findings in venous blood - RNA
timeFrame: January 2024 - December 2029
measure: Correlation of exhaled breath condensate patterns with molecular biological findings in venous blood - proteins
timeFrame: January 2024 - December 2029
measure: Correlation of exhaled breath condensate patterns with molecular biological findings in venous blood - metabolites
timeFrame: January 2024 - December 2029
Other outcomes:
Locations:
city: Olomouc
country: Czechia
facility: Institute of Molecular and Translational Medicine, Palacky University
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
Study officials:
affiliation: IMTM, Palacky University in Olomouc, Faculty of Medicine and Dentistry
name: Emil Berta, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: