Early Detection of Ventilator-associated Pneumonia (VAP)

NCT02753608 | Completed

• 1 other identifier: ZKSJ0093
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia, Ventilator-associated

Keywords

exhaled breath condensate; volatile organic compounds

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

No ventilator-associated pneumonia (VAP)

SHAM COMPARATOR

Collection of exhaled breath condensate (EBC) in patients without clinical signs of VAP

Other: Collection of exhaled breath condensate

Ventilator-associated pneumonia (VAP)

EXPERIMENTAL

Collection of exhaled breath condensate (EBC) in patients displaying clinical signs of VAP

Other: Collection of exhaled breath condensate

Interventions

Collection of exhaled breath condensate OTHER

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.

Also known as: EBC collection

No ventilator-associated pneumonia (VAP); Ventilator-associated pneumonia (VAP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ICU patients on invasive ventilation
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Jena University Hospital: lead

Study Sites (1)

Jena University Hospital

Jena, Thuringia, 07747, Germany

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mathias Pletz, MD

  Jena University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Infection Medicine and Hospital Hygiene

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 28, 2016
• Study Start: June 28, 2016
• Primary Completion: December 31, 2017
• Study Completion: March 31, 2018
• Last Updated: July 20, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)