Exhaled Breath Condensate Analysis in Mechanically Ventilated Patients

NCT ID: NCT06189924

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2029-12-31

Brief Summary

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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

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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

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Acute Respiratory Failure Critical Illness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Proteomic analysis of exhaled breath condensate

Intervention Type DIAGNOSTIC_TEST

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

Mechanically ventilated patients without lung injury

Mechanically ventilated patients without lung injury, with various pathologies. Patients will be treated at intensive care units (ICU).

Proteomic analysis of exhaled breath condensate

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Proteomic analysis of exhaled breath condensate

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Molecular biological examination of the venous blood sample

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Institute of Molecular and Translational Medicine, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emil Berta, MD PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Institute of Molecular and Translational Medicine, Palacky University

Olomouc, , Czechia

Site Status

University Hospital Olomouc

Olomouc, , Czechia

Site Status

Countries

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Czechia

Central Contacts

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Emil Berta, MD PhD

Role: CONTACT

+420585632111

Karel Axmann, MD

Role: CONTACT

+420588445356

Facility Contacts

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Emil Berta, MD PhD

Role: primary

+420585632111

Karel Axmann, MD

Role: primary

+420588445356

Other Identifiers

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64734

Identifier Type: -

Identifier Source: org_study_id

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