Exhaled Breath Condensate Analysis in Mechanically Ventilated Patients

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06189924
• Other study ID #: 64734
• Status: Not yet recruiting
• Start date: January 1, 2024
• Est. completion date: December 31, 2029

Study information

• Verified date: January 2024
• Source: The Institute of Molecular and Translational Medicine, Czech Republic
• Contact: Emil Berta, MD PhD
• Phone: +420585632111
• Email: e.berta[@]upol.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Critical Illness
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
Czechia	Institute of Molecular and Translational Medicine, Palacky University	Olomouc
Czechia	University Hospital Olomouc	Olomouc

Sponsors (1)

Lead Sponsor	Collaborator
The Institute of Molecular and Translational Medicine, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of proteomic patterns of the exhaled breath condensate in mechanically ventilated intensive care patients.	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.	January 2024 - December 2029
Secondary	Correlation of exhaled breath condensate patterns with molecular biological findings in venous blood - DNA	Venous blood sample will be analysed employing targeted analyses of DNA. The results will be correlated to proteomic patterns obtained from the exhaled breath condensate.	January 2024 - December 2029
Secondary	Correlation of exhaled breath condensate patterns with molecular biological findings in venous blood - RNA	Venous blood sample will be analysed employing targeted analyses of RNA. The results will be correlated to proteomic patterns obtained from the exhaled breath condensate.	January 2024 - December 2029
Secondary	Correlation of exhaled breath condensate patterns with molecular biological findings in venous blood - proteins	Venous blood sample will be analysed employing targeted analyses of proteins. The results will be correlated to proteomic patterns obtained from the exhaled breath condensate.	January 2024 - December 2029
Secondary	Correlation of exhaled breath condensate patterns with molecular biological findings in venous blood - metabolites	Venous blood sample will be analysed employing targeted analyses of metabolites. The results will be correlated to proteomic patterns obtained from the exhaled breath condensate.	January 2024 - December 2029