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BMC Pulm Med

Title:		BreathDx - molecular analysis of exhaled breath as a diagnostic test for ventilator-associated pneumonia: protocol for a European multicentre observational study
Author(s):		van Oort PM; Nijsen T; Weda H; Knobel H; Dark P; Felton T; Rattray NJ; Lawal O; Ahmed W; Portsmouth C; Sterk PJ; Schultz MJ; Zakharkina T; Artigas A; Povoa P; Martin-Loeches I; Fowler SJ; Bos LD; BreathDx C;
Address:		"Institute of Inflammation and Repair, University of Manchester, Oxford Road, Manchester, M13 9PL, UK. pouline.vanoort@gmail.com. Philips Research, Eindhoven, The Netherlands. Salford Royal NHS Foundation Trust, Greater Manchester, UK. University Hospital of South Manchester NHS Foundation Trust, Manchester, UK. Manchester Institute of Biotechnology (MIB), School of Chemistry, University of Manchester, Manchester, UK. Institute of Inflammation and Repair, University of Manchester, Oxford Road, Manchester, M13 9PL, UK. Intensive Care, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands. Critical Care Department, CIBER Enfermedades Respiratorias, Corporacion Sanitaria Universitaria Parc Tauli, Sabadell, Spain. Hospital de Sao Fransisco Xavier, Centro Hospitalar Lisboa Ocidental, Lisbon, Portugal. Department of Clinical Medicine, St James's Hospital, Multidisciplinary Intensive Care Research Organization (MICRO), Trinity Centre for Health Sciences, Dublin, Ireland"
Journal Title:		BMC Pulm Med
Year:		2017
Volume:		20170103
Issue:		1
Page Number:		1 -
DOI:		10.1186/s12890-016-0353-7
ISSN/ISBN:		1471-2466 (Electronic) 1471-2466 (Linking)
Abstract:		"BACKGROUND: The diagnosis of ventilator-associated pneumonia (VAP) remains time-consuming and costly, the clinical tools lack specificity and a bedside test to exclude infection in suspected patients is unavailable. Breath contains hundreds to thousands of volatile organic compounds (VOCs) that result from host and microbial metabolism as well as the environment. The present study aims to use breath VOC analysis to develop a model that can discriminate between patients who have positive cultures and who have negative cultures with a high sensitivity. METHODS/DESIGN: The Molecular Analysis of Exhaled Breath as Diagnostic Test for Ventilator-Associated Pneumonia (BreathDx) study is a multicentre observational study. Breath and bronchial lavage samples will be collected from 100 and 53 intubated and ventilated patients suspected of VAP. Breath will be analysed using Thermal Desorption - Gas Chromatography - Mass Spectrometry (TD-GC-MS). The primary endpoint is the accuracy of cross-validated prediction for positive respiratory cultures in patients that are suspected of VAP, with a sensitivity of at least 99% (high negative predictive value). DISCUSSION: To our knowledge, BreathDx is the first study powered to investigate whether molecular analysis of breath can be used to classify suspected VAP patients with and without positive microbiological cultures with 99% sensitivity. TRIAL REGISTRATION: UKCRN ID number 19086, registered May 2015; as well as registration at www.trialregister.nl under the acronym 'BreathDx' with trial ID number NTR 6114 (retrospectively registered on 28 October 2016)"
Keywords:		"Breath Tests/*methods Bronchoalveolar Lavage Fluid/microbiology Gas Chromatography-Mass Spectrometry Hospitals, University Humans Intensive Care Units Logistic Models Metabolomics Netherlands Pneumonia, Ventilator-Associated/*diagnosis/*microbiology Prosp;"
Notes:		"Medlinevan Oort, Pouline M P Nijsen, Tamara Weda, Hans Knobel, Hugo Dark, Paul Felton, Timothy Rattray, Nicholas J W Lawal, Oluwasola Ahmed, Waqar Portsmouth, Craig Sterk, Peter J Schultz, Marcus J Zakharkina, Tetyana Artigas, Antonio Povoa, Pedro Martin-Loeches, Ignacio Fowler, Stephen J Bos, Lieuwe D J eng Multicenter Study Observational Study Research Support, Non-U.S. Gov't England 2017/01/05 BMC Pulm Med. 2017 Jan 3; 17(1):1. doi: 10.1186/s12890-016-0353-7"