TY - JOUR
T1 - BreathDx - molecular analysis of exhaled breath as a diagnostic test for ventilator-associated pneumonia: protocol for a European multicentre observational study
AU - van Oort, Pouline M. P.
AU - Nijsen, Tamara
AU - Weda, Hans
AU - Knobel, Hugo
AU - Dark, Paul
AU - Felton, Timothy
AU - Rattray, Nicholas J. W.
AU - Lawal, Oluwasola
AU - Ahmed, Waqar
AU - Portsmouth, Craig
AU - Sterk, Peter J.
AU - Schultz, Marcus J.
AU - Zakharkina, Tetyana
AU - Artigas, Antonio
AU - Povoa, Pedro
AU - Martin-Loeches, Ignacio
AU - Fowler, Stephen J.
AU - Bos, Lieuwe D. J.
AU - AUTHOR GROUP
AU - Camprubi, Marta
AU - Coelho, Luis
AU - Davie, Alan
AU - Diaz, Emili
AU - Goma, Gemma
AU - Goodacre, Royston
AU - Leopold, Jan-Hendrik
AU - Rijnders, Guus
AU - Steenwelle, Ruud
AU - Valles, Jordi
AU - Verhoeckx, Fred
AU - Vink, Anton
AU - Winters, Tineke
PY - 2017
Y1 - 2017
N2 - 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. 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). 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. 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)
AB - 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. 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). 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. 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)
U2 - https://doi.org/10.1186/s12890-016-0353-7
DO - https://doi.org/10.1186/s12890-016-0353-7
M3 - Article
C2 - 28049457
SN - 1471-2466
VL - 17
SP - 1
JO - BMC Pulmonary Medicine
JF - BMC Pulmonary Medicine
IS - 1
ER -