Early Detection of Ventilator-associated Pneumonia (VAP) (cheqVAP)
Primary Purpose
Pneumonia, Ventilator-associated
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Collection of exhaled breath condensate
Sponsored by
About this trial
This is an interventional diagnostic trial for Pneumonia, Ventilator-associated focused on measuring exhaled breath condensate, volatile organic compounds
Eligibility Criteria
Inclusion Criteria:
- ICU patients on invasive ventilation
- Signed informed consent
Exclusion Criteria:
- Glucocorticoid dosage above 0.3 mg/kg Prednisolone equivalent over more than 3 weeks
- Treatment with recognized T cell immunosuppressant (cyclosporine, Tumor Necrosis Factor antagonists) or nucleoside analogues during the preceding 90 days
- Inherited severe immunodeficiency
- Solid organ or stem cell transplant recipients
- Anti-cancer chemotherapy during the preceding 90 days
Sites / Locations
- Jena University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
No ventilator-associated pneumonia (VAP)
Ventilator-associated pneumonia (VAP)
Arm Description
Collection of exhaled breath condensate (EBC) in patients without clinical signs of VAP
Collection of exhaled breath condensate (EBC) in patients displaying clinical signs of VAP
Outcomes
Primary Outcome Measures
Raman spectra of volatile organic compounds in exhaled breath condensates in the absence or presence of VAP
Raman spectrum of volatile organic compounds
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02753608
Brief Title
Early Detection of Ventilator-associated Pneumonia (VAP)
Acronym
cheqVAP
Official Title
Exhalate Sample Collection for Raman Spectroscopy-based Early Detection of Ventilator-associated Pneumonia (VAP)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 28, 2016 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
March 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jena University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study goal consists in the sequential collection of exhaled breath condensates (EBC) from patients receiving invasive ventilation. Subsequent Raman spectroscopy aims at the identification of putative biomarkers that could enable rapid early distinction of Ventilator-associated pneumonia.
Detailed Description
Diagnostics of VAP relies on two complementary strategies: meeting pre-defined clinical criteria and evidence of pathogens in the lower respiratory tract. Mere reliance on clinical symptoms, such as radiologic evidence, systemic signs of inflammation and indices of compromised pulmonary function reportedly lead to misdiagnosis. Current diagnostic procedures recommend gathering of evidence for new or progressive lung infiltrates from serial chest radiographies, together with co-existing clinical signs of impaired respiratory function. Microbiological confirmation of pathogen presence requires examination of airway secretions collected by invasive bronchoalveolar lavage which demands specific technical skills and staff training. Although verification of causal pathogens is essential for the introduction of targeted antibiotic therapy, the procedure is time-consuming and qualitative in reportedly less than 30 % of the cases. Furthermore, the currently adopted diagnostic approaches are based on sporadic information sampling and do not support continuous monitoring and evaluation of the effect of therapeutic interventions. All above-listed flaws and shortcomings emphasize the need for rapid, reliable and non-invasive recognition of VAP, preferably in a setting that would permit continuous bedside monitoring and timely introduction of targeted drug therapy.
The study objective consists in sequential collection of exhaled breath condensates (EBC) in ICU patients receiving invasive ventilation. The EBC samples will be subjected to determination of volatile organic compound (VOC) profiles by Stimulated Raman Spectroscopy (SRS) which, upon individual matching to routinely collected clinical parameters, may become putative biomarkers for the early recognition of VAP. Evidence has accumulated in support of the assumption that certain metabolites in EBC might display significant profile differences as to their size, hydrophobicity and electrical charge. Identification of VAP-specific profiles of VOC will provide the basis for the generation of a data base enabling the construction and standardization of a bedside device for continuous real-time point-of-care monitoring of VAP hazard in patients on invasive ventilation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Ventilator-associated
Keywords
exhaled breath condensate, volatile organic compounds
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No ventilator-associated pneumonia (VAP)
Arm Type
Sham Comparator
Arm Description
Collection of exhaled breath condensate (EBC) in patients without clinical signs of VAP
Arm Title
Ventilator-associated pneumonia (VAP)
Arm Type
Experimental
Arm Description
Collection of exhaled breath condensate (EBC) in patients displaying clinical signs of VAP
Intervention Type
Other
Intervention Name(s)
Collection of exhaled breath condensate
Other Intervention Name(s)
EBC collection
Intervention Description
An sampling device (authorized for this use) will be connected to the expiratory line of the ventilator. Exhaled breath condensates accumulate in a cooled container.
Primary Outcome Measure Information:
Title
Raman spectra of volatile organic compounds in exhaled breath condensates in the absence or presence of VAP
Description
Raman spectrum of volatile organic compounds
Time Frame
24 hours upon clinical diagnosis confirmation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ICU patients on invasive ventilation
Signed informed consent
Exclusion Criteria:
Glucocorticoid dosage above 0.3 mg/kg Prednisolone equivalent over more than 3 weeks
Treatment with recognized T cell immunosuppressant (cyclosporine, Tumor Necrosis Factor antagonists) or nucleoside analogues during the preceding 90 days
Inherited severe immunodeficiency
Solid organ or stem cell transplant recipients
Anti-cancer chemotherapy during the preceding 90 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathias Pletz, MD
Organizational Affiliation
Jena University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jena University Hospital
City
Jena
State/Province
Thuringia
ZIP/Postal Code
07747
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will be not made available
Learn more about this trial
Early Detection of Ventilator-associated Pneumonia (VAP)
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