HOspital Versus Primary Care Breath Test Environment (HOPE) Study
ConditionBreath Test
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorImperial College London
About this trial
Through the HOPE study, the intention would be to determine whether exhaled breath volatile organic compound (VOC) profiles in Primary care differ from Secondary care. The intention would also be to assess intra-subject variability of participants. This would allow us to determine if the results of breath samples are reproducible regardless of whether they are performed in a Primary or Secondary care environment. This would support the clinical translation of breath research outcomes from studies performed in Secondary care, despite the breath test being intended for use in Primary care.
The chief investigator of the HOPE study is Professor George Hanna (Head of Department of Surgery and Cancer, and Professor of Surgical Sciences at Imperial College London).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged ≥ 18 years old
Willing and able to provide informed consent to take part in study.
Disqualifiers
Pregnant women will be excluded from this study. With the exception of pregnant women, there are no additional strict exclusion criteria as individuals will act as their own control.
Trial population
Volunteers will be recruited to provide breath samples in both Primary and Secondary Care environments.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Breath test
Diagnostic testParticipants will perform breath testing in Primary care followed by Secondary care on Day 1. At each location, participants will be asked to perform three breath tests (15 minutes apart). The environmental air will also be sampled. This entire process will be repeated in the reverse order (i.e. breath testing in Secondary care followed by Primary care on Day 2). Participants will be asked to maintain a clear fluid diet for a minimum of six hours prior to breath collection on both Day 1 and Day 2 of sampling.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Volunteers taking part in study1 intervention
Trial outcomes
Primary outcomes
1
The variation in exhaled breath VOC profile in the participants in Primary versus Secondary Care setting.
An exploratory analysis will be performed to identify and exclude contaminated samples. Linear mixed models will be fitted for each compound's measurements to estimate components of variation (between individuals, occasions and repeat samples), and confirm that there is no effect of ordering (hospital-GP vs GP-hospital). Repeatability of each day-location combination will be summarised as the intra-class correlation coefficient (ICC) and the coefficient of variation (CV). The observed differences will be compared with the clinically acceptable limits for each VOC to identify the proportion of GP-hospital differences that fall within these limits. For each VOC, the ICC, CV and the limits of agreement with 95% confidence interval will be reported, along with how they compare with the clinically acceptable differences.
Time frame
2 yearsSecondary outcomes
1
The intra-subject variability in exhaled breath VOCs when breath is sampled 15 minutes apart on different days.
Please see \"Description\" for \"Primary Outcome Measure\".
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov