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Early Detection of Ventilator-associated Pneumonia (VAP) (cheqVAP)

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ClinicalTrials.gov Identifier: NCT02753608
Recruitment Status : Completed
First Posted : April 28, 2016
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Mathias Pletz, Jena University Hospital

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.

Condition or disease Intervention/treatment Phase
Pneumonia, Ventilator-associated Other: Collection of exhaled breath condensate Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Exhalate Sample Collection for Raman Spectroscopy-based Early Detection of Ventilator-associated Pneumonia (VAP)
Actual Study Start Date : June 28, 2016
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Sham Comparator: No ventilator-associated pneumonia (VAP)
Collection of exhaled breath condensate (EBC) in patients without clinical signs of VAP
Other: Collection of exhaled breath condensate
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.
Other Name: EBC collection

Experimental: Ventilator-associated pneumonia (VAP)
Collection of exhaled breath condensate (EBC) in patients displaying clinical signs of VAP
Other: Collection of exhaled breath condensate
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.
Other Name: EBC collection




Primary Outcome Measures :
  1. Raman spectra of volatile organic compounds in exhaled breath condensates in the absence or presence of VAP [ Time Frame: 24 hours upon clinical diagnosis confirmation ]
    Raman spectrum of volatile organic compounds



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02753608


Locations
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Germany
Jena University Hospital
Jena, Thuringia, Germany, 07747
Sponsors and Collaborators
Jena University Hospital
Investigators
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Principal Investigator: Mathias Pletz, MD Jena University Hospital

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Responsible Party: Mathias Pletz, Director, Center for Infection Medicine and Hospital Hygiene, Jena University Hospital
ClinicalTrials.gov Identifier: NCT02753608     History of Changes
Other Study ID Numbers: ZKSJ0093
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will be not made available
Keywords provided by Mathias Pletz, Jena University Hospital:
exhaled breath condensate
volatile organic compounds
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection