Sputum induction is considered a relatively non-invasive, reliable procedure, which can be utilised to characterise the inflammatory profile of the airways. However, 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.
This is a single centre, crossover study to compare the use of two nebulisers in the sputum induction procedure. 54 participants with stable asthma or COPD will be recruited and will attend 2 visits, at least 48 hours apart. Differences in the quality and quantity of samples and the time taken to produce a sample will 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. 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 the event of unsuccessful procedures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
54
The Omron Ultrasonic nebuliser dispenses sterile saline from a medication cup as an aerosol, which is inhaled.
The Akita Jet Inhalation System is a breath actuated nebuliser, which works with a positive pressure.
Nottingham Respiratory Research Unit
Nottingham, United Kingdom
RECRUITINGThe tolerability to sputum induction test
Checking discomfort degree due to inhalation of hypertonic saline assessed by a visual analogue scale (0 to 10)
Time frame: During the visit, after each cycle of nebulisation (each 5 minutes)
Spirometry
Measurement of lung function (FEV1 and FEV1%pred)
Time frame: During the visit, up to 4 hours
Borg Scale
Measurement of dyspnoea levels
Time frame: During the visit, up to 4 hours
The quality of sputum samples
The analysis of squamous contamination in the sample (if \>40%), viability (\>65% of life cells) and quality of slide for differential cells count
Time frame: During the processing time, 2 hours
The quantity of sputum samples
How much sputum sample was produced of sufficient quality for processing
Time frame: During the visit, up to 4 hours
Time to produce sample
The time in minutes required to produce a sputum sample sufficient for processing
Time frame: During the visit, up to 30 minutes
Saline quantity
The amount of sterile saline required to produce a sputum sample sufficient for processing
Time frame: During the visit, up to 30 minutes
Influence of Physiotherapy techniques
The influence of manual vibrations and Huff cough in producing a sputum sample after unsuccessful induction attempts
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Time frame: During the study visit, up to 5 minutes