Exhaled Breath Condensate Analysis in Mechanically Ventilated Patients

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Critical Illness; Acute Respiratory Failure
• Intervention / Treatment: Diagnostic test: Proteomic analysis of exhaled breath condensate

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Emil Berta, MD PhD; Phone Number: +420585632111; Email: e.berta@upol.cz
• Study Contact Backup: Name: Karel Axmann, MD; Phone Number: +420588445356; Email: karel.axmann@fnol.cz

Study Locations

• Czechia
  • Olomouc, Czechia, 77900
    • University Hospital Olomouc
    • Contact: Karel Axmann, MD; Phone Number: +420588445356; Email: karel.axmann@fnol.cz
  • Olomouc, Czechia, 77900
    • Institute of Molecular and Translational Medicine, Palacky University
    • Contact: Emil Berta, MD PhD; Phone Number: +420585632111; Email: e.berta@upol.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Mechanically ventilated intensive care patients with or without acute hypoxemic respiratory failure

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Diagnostic test: Proteomic analysis of exhaled breath condensate; Mechanically ventilated intensive care patients will be sampled for exhaled breath condensate from the ventilator circuit.; Other Names: Molecular biological examination of the venous blood sample
Mechanically ventilated patients without lung injury; Mechanically ventilated patients without lung injury, with various pathologies. Patients will be treated at intensive care units (ICU).	Diagnostic test: Proteomic analysis of exhaled breath condensate; Mechanically ventilated intensive care patients will be sampled for exhaled breath condensate from the ventilator circuit.; Other Names: Molecular biological examination of the venous blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: The Institute of Molecular and Translational Medicine, Czech Republic
• Investigators: Principal Investigator: Emil Berta, MD PhD, IMTM, Palacky University in Olomouc, Faculty of Medicine and Dentistry

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: January 2, 2024
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: mechanical ventilation; genomics; intensive care; lung injury; acute respiratory failure; proteomics; exhaled breath condensate
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Respiratory Insufficiency; Critical Illness
• Other Study ID Numbers: 64734

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No