Exhaled Breath Condensate Analysis in Mechanically Ventilated Patients

Not yet recruiting

• Conditions: Acute Respiratory Failure; Critical Illness
• Interventions: Diagnostic Test: Proteomic analysis of exhaled breath condensate

• Registration Number: NCT06189924
• Lead Sponsor: The Institute of Molecular and Translational Medicine, Czech Republic

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 Timeline

• Study First Submitted: 2023-12-04
• Status Verified: 2024-01
• Study Start: 2024-01-01
• Study First Submitted QC: 2024-01-02
• Last Update Submitted: 2024-01-02
• Study First Posted: 2024-01-05
• Last Update Posted: 2024-01-05
• Primary Completion: 2028-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mechanically ventilated patients with primary or secondary lung injury	Proteomic analysis of exhaled breath condensate	Mechanically ventilated patients with primary or secondary lung injury due to various pathologies. Patients will be treated at intensive care units (ICU).
Mechanically ventilated patients without lung injury	Proteomic analysis of exhaled breath condensate	Mechanically ventilated patients without lung injury, with various pathologies. Patients will be treated at intensive care units (ICU).

Primary Outcome Measures

Name	Time	Method
Comparison of proteomic patterns of the exhaled breath condensate in mechanically ventilated intensive care patients.	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 Outcome Measures

Name	Time	Method
Correlation of exhaled breath condensate patterns with molecular biological findings in venous blood - proteins	January 2024 - December 2029	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.
Correlation of exhaled breath condensate patterns with molecular biological findings in venous blood - DNA	January 2024 - December 2029	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.
Correlation of exhaled breath condensate patterns with molecular biological findings in venous blood - RNA	January 2024 - December 2029	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.
Correlation of exhaled breath condensate patterns with molecular biological findings in venous blood - metabolites	January 2024 - December 2029	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.

Trial Locations

Locations (2)

Institute of Molecular and Translational Medicine, Palacky University; 🇨🇿 Olomouc, Czechia

University Hospital Olomouc; 🇨🇿 Olomouc, Czechia