Acute Respiratory FailureNCT06189924
Exhaled Breath Condensate Analysis in Mechanically Ventilated Patients
An observational study of Acute Respiratory Failure and Critical Illness, run by The Institute of Molecular and Translational Medicine, Czech Republic at 2 sites in Czechia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, Critical Illness
- What is being tested?
- Proteomic analysis of exhaled breath condensate
- How many people
- 200 participants
- Where
- 2 sitesCzechia
- Study dates
- 1 Mar 2026to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mechanically ventilated intensive care patients with or without acute hypoxemic respiratory failure
Who may be able to join
- Intensive care setting Mechanical ventilation Ventilator/ventilator circuit technically suitable for sampling of exhaled breath condensate
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia2 sites, 2 recruiting
- Recruiting
Institute of Molecular and Translational Medicine, Palacky University
Olomouc, 77900
Emil Berta, MD PhD, +420585632111, e.berta@upol.cz
- Recruiting
University Hospital Olomouc
Olomouc, 77900
Karel Axmann, MD, +420588445356, karel.axmann@fnol.cz
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Respiratory Failure, Critical Illness
- Being tested
- Proteomic analysis of exhaled breath condensate
- Keywords
- exhaled breath condensate, proteomics, genomics, mechanical ventilation, acute respiratory failure, lung injury, intensive care
- Medical subject headings
- Critical Illness, Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proteomic analysis of exhaled breath condensateDiagnostic test
Also called Molecular biological examination of the venous blood sample
Mechanically ventilated intensive care patients will be sampled for exhaled breath condensate from the ventilator circuit.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Diagnostic Test: Proteomic analysis of exhaled breath condensate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: January 2024 - December 2029
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: January 2024 - December 2029
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Mar 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Institute of Molecular and Translational Medicine, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emil Berta, MD PhD, Principal investigator, IMTM, Palacky University in Olomouc, Faculty of Medicine and Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189924
- Sponsor's protocol ID
- 64734
- Status last verified
- Jun 2026
- First submitted
- 4 Dec 2023
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomic Analysis of Exhaled Breath Condensate in Mechanically Ventilated Intensive Care Patients
- ClinicalTrials.gov ID
- NCT06189924
- Acronym / sponsor ID
- 64734
- Conditions
- Acute Respiratory Failure, Critical Illness
- Keywords
- exhaled breath condensate, proteomics, genomics, mechanical ventilation, acute respiratory failure, lung injury, intensive care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Institute of Molecular and Translational Medicine, Czech RepublicUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanically ventilated patients with primary or secondary lung injury | – | Diagnostic Test: Proteomic analysis of exhaled breath condensateMechanically 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 | – | Diagnostic Test: Proteomic analysis of exhaled breath condensateMechanically ventilated patients without lung injury, with various pathologies. Patients will be treated at intensive care units (ICU). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilated intensive care patients with or without acute hypoxemic respiratory failure
Key inclusion criteria (1 listed)
- Intensive care setting Mechanical ventilation Ventilator/ventilator circuit technically suitable for sampling of exhaled breath condensate
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proteomic analysis of exhaled breath condensateAlso: Molecular biological examination of the venous blood sampleMechanically ventilated intensive care patients will be sampled for exhaled breath condensate from the ventilator circuit. | Diagnostic test | Mechanically ventilated patients with primary or secondary lung injury, Mechanically ventilated patients without lung injury |
Primary outcome
Comparison of proteomic patterns of the exhaled breath condensate in mechanically ventilated intensive care patients.
Time frame: 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.
4 secondary outcomes
Correlation of exhaled breath condensate patterns with molecular biological findings in venous blood - DNA
Time frame: January 2024 - December 2029
Correlation of exhaled breath condensate patterns with molecular biological findings in venous blood - RNA
Time frame: January 2024 - December 2029
Correlation of exhaled breath condensate patterns with molecular biological findings in venous blood - proteins
Time frame: January 2024 - December 2029
Correlation of exhaled breath condensate patterns with molecular biological findings in venous blood - metabolites
Time frame: January 2024 - December 2029
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emil Berta, MD PhD principal investigator
IMTM, Palacky University in Olomouc, Faculty of Medicine and Dentistry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure and Critical Illness, run by The Institute of Molecular and Translational Medicine, Czech Republic at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emil Berta, MD PhD (+420585632111, e.berta@upol.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of proteomic patterns of the exhaled breath condensate in mechanically ventilated intensive care patients. (time frame: January 2024 - December 2029). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.