NCT06189924

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
42mo left

Started Mar 2026

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Mar 2026Dec 2029

First Submitted

Initial submission to the registry

December 4, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
2.2 years until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

June 25, 2026

Status Verified

June 1, 2026

Enrollment Period

2.8 years

First QC Date

December 4, 2023

Last Update Submit

June 23, 2026

Conditions

Critical IllnessAcute Respiratory Failure

Keywords

exhaled breath condensateproteomicsgenomicsmechanical ventilationacute respiratory failurelung injuryintensive care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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 - proteins

    January 2024 - December 2029

  • Correlation of exhaled breath condensate patterns with molecular biological findings in venous blood - metabolites

    January 2024 - December 2029

Study Arms (2)

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 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

Interventions

Proteomic analysis of exhaled breath condensateDIAGNOSTIC_TEST

Mechanically ventilated intensive care patients will be sampled for exhaled breath condensate from the ventilator circuit.

Also known as: Molecular biological examination of the venous blood sample
Mechanically ventilated patients with primary or secondary lung injuryMechanically ventilated patients without lung injury

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Intensive care setting Mechanical ventilation Ventilator/ventilator circuit technically suitable for sampling of exhaled breath condensate

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institute of Molecular and Translational Medicine, Palacky University

Olomouc, 77900, Czechia

RECRUITING

University Hospital Olomouc

Olomouc, 77900, Czechia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood

MeSH Terms

Conditions

Critical IllnessLung Injury

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLung DiseasesRespiratory Tract DiseasesThoracic InjuriesWounds and Injuries

Study Officials

  • Emil Berta, MD PhD

    IMTM, Palacky University in Olomouc, Faculty of Medicine and Dentistry

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emil Berta, MD PhD

CONTACT

+420585632111e.berta@upol.cz

Karel Axmann, MD

CONTACT

+420588445356karel.axmann@fnol.cz

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2023

First Posted

January 5, 2024

Study Start

March 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Last Updated

June 25, 2026

Record last verified: 2026-06

Locations

CZ(2)