Respiratory Respiratory
Conditions
Interventions
Subjects will be recruited from patients attending the Lung Investigation Unit for routine spirometry testing and from healthy volunteers working within the department. The test procedure will not ent
Sponsors
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects will be recruited from those routinely referred to the department for lung function testing. These patients will have been referred to the department either directly from primary care from their General Practitioner or in secondary care following a consultation with a respiratory physician from within UHB Foundation Trust. Upon receiving the referral for testing, all potential patients (ie only those that have been referred for tests involving spirometric measurements) will be sent the information leaflet together with the standard appointment letter asking if they would be interested in taking part in the study. A contact phone number for the Chief Investigator will be supplied and patients may have the opportunity to ask any questions either by telephone or via a prior visit to the Lung investigation Unit. On the day of the test, all participants will sign a consent form and then testing will proceed according to the protocol. All subjects will be given adequate time to consider whether they wish to take part in the research programme. Appointment letters together with patient information leaflets will be sent out at least two weeks prior to the test date in order to enable patients to ask any questions should they wish to do so. If they agree to participate the consent form will be signed when the patient arrives for the appointment prior to any tests being performed. If patients do not wish to take part in the programme, their usual care will not be affected. They will be instructed to attend the appointment for the tests as per normal and the test will performed according to routine laboratory protocols, with no extra measurements being made. In addition, healthy volunteers will be included and will be recruited from individuals working within the Lung investigation Unit. These individuals will be asked to read the patient information leaflet and, if they agree to participate, the tests will be scheduled at their convenience and without disruption to the usual clinical workload.
Exclusion criteria
Exclusion criteria: 1. Individuals that have been referred for tests other than spirometry eg exercise testing, sleep investigations will not receive a patient information leaflet and therefore will be excluded from the study. 2. Those patients that are unable to perform technically acceptable spirometry - this will be ascertained during the testing procedure. If patients have difficulty performing the manoeuvres the physiologist will revert to the usual testing procedure using standard equipment and the patient will not be required to continue with the additional tests required for the research protocol. 3. Standard contraindications to lung function testing (ATS, 1994) such as haemoptysis, recent chest infection, recent eye or abdominal surgery, recent pneumothorax, recent myocardial infarction and acute disorders such as vomiting or diarrhoea.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the comparison of the results obtained between different spirometric devices: 1. The variability of the measurements obtained using the new equipment versus both the gold standard and other flow measuring devices 2. The accuracy of the measurements obtained with the new equipment versus the gold standard and other flow measuring devices. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed