A Comparison of Two Nebulisers for Sputum Induction
Research type
Research Study
Full title
An Comparison of Two Nebulisers for Performing Sputum Induction to Assess Airway Inflammation.
IRAS ID
241883
Contact name
Tim Harrison
Contact email
Sponsor organisation
University of Nottingham
Duration of Study in the UK
0 years, 7 months, 0 days
Research summary
Research Summary
Sputum induction was referred to more than one century ago and described in 1958. It is considered a relatively non-invasive, reliable procedure which can be utilised to characterise the inflammatory profile of the airways and direct clinicians towards personalised treatment. Despite this, the procedure can be slightly uncomfortable for patients.This study aims to assess the differences in participants tolerability of sputum induction, by comparing two different nebulisers when performing the procedure. Any differences in the quality and quantity of samples will also be described. The main purpose is to explore the optimum device to perform the procedure, whilst protecting the safety of participants and maximising their comfort.
We will recruit 54 participants with either stable Asthma or stable Chronic Obstructive Pulmonary Disease (COPD), from the Nottingham Respiratory Research Database or from Respiratory Out-patient clinics. They will attend two visits at the Nottingham Respiratory Research Unit, at least 48 hours apart. Following Informed Consent at Visit 1, a limited medical history will be collected. At Visit 1 participants will complete questionnaires to assess disease stability. At both Visits 1 and 2, they will perform lung function testing (spirometry) and have sputum induction. They will also complete visual analogue scales to assess comfort and the BORG scale to assess dyspnoea.
This is a crossover study, so participants that begin the study with nebuliser A will repeat the procedure at Visit 2, with nebuliser B and vice-versa.
If participants are unable to produce a sputum sample after completion of the induction procedure, physiotherapy techniques may be performed. This is an exploratory objective to establish whether these techniques may help in unsuccessful tests.
Summary of Results
This study aimed to compare two different types of nebuliser machines, which could be used to perform the sputum induction procedure. This is a test used to verify the inflammation present in the airways (breathing tubes). The test is performed by the inhalation of salt water through a nebuliser to stimulate a cough, which helps to bring up sputum/mucus, from areas closer to the lungs. The first nebuliser (ultrasonic nebuliser = UN) has been largely used to perform this test, however the second nebuliser (breath-actuated jet nebuliser = BAN) has not been routinely used for this test before. To take part in this study, participants were required to have asthma or COPD and be using inhaled medication to treat their disease.
We had two main objectives in this study. Firstly, we wished to assess if one nebuliser was better tolerated by participants, than the other. Secondly, we wished to assess if there were any differences between the nebulisers in respect of safety and quality of the sputum samples once laboratory analysis was performed.Data from thirty five from a total of thirty seven enrolled participants was included in the study. Participants underwent two visits at the Nottingham Respiratory Biomedical Research Centre at Nottingham City Hospital. We divided the participants into 2 groups depending on the nebuliser they used at Visit 1. Group A (19) used BAN on Visit 1 and UN at Visit 2; while group B used UN at Visit 1 and BAN at Visit 2. The participants were allocated by chance (randomised) to these groups. The study was disrupted by the pandemic due to the nature of the sputum induction procedure, which is classified as an aerosol generator procedure.
In total, it was completed 69 tests. The tolerance was assessed using two instruments. The BORG scale measures the dyspnoea (breathlessness) sensation and the Visual Analogue Scale (VAS) scored between 0 and 10 identified how much uncomfortable the test was according to patient's perception. The BORG and VAS favoured BAN, which it was better tolerated than UN. However, the study showed that the test was safe and not dependent on the type of nebuliser.
Safety measurements such as oxygen saturation (SpO2) and FEV1 (lung function – blow capacity) were assessed after each inhalation with salt water, and there were no differences between devices in average fall of FEV1 or SpO2 during the test.
There were 41 tests with sufficient samples to be able to undergo laboratory analysis. Fifty-one percent of the tests with BAN were good and 66% with UN (non-statistical difference). No differences were observed in parameters that classified sample's quality.Conclusions
• The sputum induction tests performed with the BAN were better tolerated (83%) than with the UN (50%).
• Safety measures were similar with both nebulisers.
• The quantity of tests which produced sufficient samples to be analysed in the laboratory were similar with both nebulisers.
• The quality of the samples analysed in the laboratory were similar with both nebulisers.REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
18/EM/0140
Date of REC Opinion
3 Jul 2018
REC opinion
Further Information Favourable Opinion