A comparison of devices for measurement of spirometry in normal healthy subjects and patients with respiratory disease

Not Applicable

Completed

• Conditions: Respiratory

• Registration Number: ISRCTN85273398
• Lead Sponsor: Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-29
• Study Completion: 2016-01-01
• Last Update Posted: 2 July 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified