The VICTORY (Investigation of Inflammacheck to Measure Exhaled Breath Condensate Hydrogen Peroxide in Respiratory Conditions) Study: Protocol for a Cross-sectional Observational Study.

ABSTRACT

BACKGROUND: More than 7% of the world's population is living with a chronic respiratory condition. In the United Kingdom, lung disease affects approximately 1 in 5 people, resulting in over 700,000 hospital admissions each year. People with respiratory conditions have several symptoms and can require multiple health care visits and investigations before a diagnosis is made. The tests available can be difficult to perform, especially if a person is symptomatic, leading to poor quality results. A new, easy-to-perform, point-of-care test that can be performed in any health care setting and that can differentiate between various respiratory conditions would have a significant, beneficial impact on the ability to diagnose respiratory diseases. OBJECTIVE: The objective of this study is to use a new handheld device (Inflammacheck) in different respiratory conditions to measure the exhaled breath condensate hydrogen peroxide (EBC H2O2) and compare these results with those of healthy controls and with each other. This study also aims to determine whether the device can measure other parameters, including breath humidity, breath temperature, breath flow dynamics, and end tidal carbon dioxide. METHODS: We will perform a single-visit, cross-sectional observational study of EBC H2O2 levels, as measured by Inflammacheck, in people with respiratory disease and volunteers with no known lung disease. Participants with a confirmed diagnosis of asthma, chronic obstructive pulmonary disease, lung cancer, bronchiectasis, pneumonia, breathing pattern disorder, and interstitial lung disease as well as volunteers with no history of lung disease will be asked to breathe into the Inflammacheck device to record their breath sample. RESULTS: The results from this study will be available in 2022, in anticipation of COVID-19-related delays. CONCLUSIONS: This study will investigate the EBC H2O2, as well as other exhaled breath parameters, for use as a future diagnostic tool.