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

Exhalate Sample Collection for Raman Spectroscopy-based Early Detection of Ventilator-associated Pneumonia (VAP)

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia, Ventilator-associated
• Intervention / Treatment: Other: Collection of exhaled breath condensate

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Thuringia
    • Jena, Thuringia, Germany, 07747
      • Jena University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: EBC collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Raman spectra of volatile organic compounds in exhaled breath condensates in the absence or presence of VAP	Raman spectrum of volatile organic compounds	24 hours upon clinical diagnosis confirmation

Collaborators and Investigators

• Sponsor: Jena University Hospital
• Investigators: Principal Investigator: Mathias Pletz, MD, Jena University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2016
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): March 31, 2018

Study Registration Dates

• First Submitted: March 31, 2016
• First Submitted That Met QC Criteria: April 27, 2016
• First Posted (Estimate): April 28, 2016

Study Record Updates

• Last Update Posted (Actual): July 20, 2018
• Last Update Submitted That Met QC Criteria: July 19, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: volatile organic compounds; exhaled breath condensate
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: ZKSJ0093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data will be not made available