Measure of exhaled breath temperature in patients with sarcoidosis
Research type
Research Study
Full title
Measure of exhaled breath temperature (EBT) in patients with sarcoidosis
IRAS ID
215820
Contact name
Athol U Wells
Contact email
Sponsor organisation
Royal Brompton Hospital
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 6 months, 30 days
Research summary
Since "heat" is one of the cardinal signs of inflammation, some authors have recently endorsed the potential value of exhaled breath temperature (EBT) in detecting inflammatory changes in airway walls and adjacent structures. The temperature of airways in human subjects can be measured using the newest third-generation device, the xhalo, a simple, non-invasive and user-friendly device.
EBT was investigated in asthma, COPD, infection, and lung cancer, but not in sarcoidosis. It is recognized that in sarcoidosis, airway inflammation may occur in isolation or may coexist with in restrictive parenchymal lung disease. The role of airway inflammation in the pathogenesis of pulmonary sarcoidosis is poorly understood, in part because of the lack of validated qauntification tools. The aims of our study are: a) to determine whether EBT measurment provides abnormal signal in sarcoidosis, compared to normal control subjects; b) to examine the variability of EBT measurments made at a single point in time, to determine whether EBT can be captured reliably with a single measurmentc; c) to evaluate construct validity of EBT by exploration of correlations with pulmonary function tests, clinical data and, in a patient subset, evidence of bronchocetnric disease on HRCT.
We planned to enrolle 80 sarcoid patients, on the same day as pulmonary function test, performed as part of clinical management. Apart from EBT measurments, no other additional tests will be performed for the purpose of the study.Exhaled breath temperature measurement
EBT will be measured with an X-halo device (Delmedica Investments, Singapore) according to previously validated methods. Briefly, patients will be requested to inhale freely through the nose and to exhale into the device at a rate and depth typical of their normal tidal-breathing rhythm. Ambient temperature will be tested and registered for each measurement with an external thermometer.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
18/LO/1413
Date of REC Opinion
25 Jan 2019
REC opinion
Further Information Favourable Opinion