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Evaluation of A Novel Sputum Clearance Technique
Evaluation of A Novel Sputum Clearance Technique
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Evaluation of a novel sputum clearance technique−−hydro-acoustic therapy (HAT) in adult patients with
cystic fibrosis: A feasibility study
NA Jarad, T. Powell and E. Smith
Chronic Respiratory Disease 2010 7: 217
DOI: 10.1177/1479972310376082
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What is This?
Abstract
This study was designed to investigate the efficacy, safety and patients’ acceptance of a novel system for sputum
clearance—Hydro Acoustic Therapy (HAT) in patients with cystic fibrosis (CF). This is a prospective cross-
over study where 18 patients received 6 sessions of physiotherapy over 6 separate days. These consisted
of 2 sessions of either HAT, flutter valve or and sitting in the bath with sounds without vibration (placebo) for
30 minutes each. The efficacy was investigated by measuring the weight of wet and dry sputum after each
session and by change in spirometry values. The preference was assessed by a questionnaire completed by
patients at the end of the study about their preference of which type of physiotherapy received. The weight
of both dry and wet sputum produced was similar in the 3 arms of the study. Spirometry values but not oxygen
saturation were reduced after HAT and flutter therapy sessions. HAT therapy was preferred to flutter and
placebo in terms of breathlessness, ease of sputum production and relaxation. Of the patients, 70% stated
that they would choose HAT as their preferred physiotherapy method compared to 0% for flutter (w2 ¼
20.3, p < 0.0001). There were no procedure-related complications in any of the 3 arms of the study. HAT was
found to be safe, well tolerated and favoured by the majority of CF patients. The effect of HAT, however, on
sputum production was not superior to flutter or placebo.
Keywords
cystic fibrosis, physiotherapy, hydro-acoustic therapy, spirometry, sputum clearance
sputum, which is responsible for increased sputum volume in the first second (FEV1) < 80% of predicted
viscosity.10,11 Other agents such as inhaled hyperos- value and baseline oxygen saturation on room air of
molic drugs are used. Both high concentration saline over 85%.
(hypertonic saline)12 and mannitol13 in CF patients Patients were excluded if they were chronically
has been found to be effective. infected with Burkhulderia Cenocepacia or were
A recent systematic review of clinical trials found dependent on oxygen due to hypoxia or dyspnoea.
no difference in the efficacy of conventional chest Exclusion criteria also included suspected pregnancy,
physiotherapy to self-administered airway clearance fear of water or pneumothorax within the previous
techniques in CF patients.14 Several other studies 3 months.
attempted to compare available methods of chest phy- All patients were enrolled during a period of clini-
siotherapy in CF patients with the aim of identifying cal stability. For the purpose of this study, this is
the most effective technique. The majority of these defined as being away from any pulmonary exacerba-
studies found little difference in the volume of sputum tions requiring oral or intravenous (IV) antibiotics for
produced and change in lung function tests.15,16 at least 4 weeks. If exacerbations occurred at any time
In clinical practice, the method of physiotherapy in the study, the next treatment was postponed by at
advised for each individual patient depends largely least 4 weeks. If patient had two exacerbations, it was
on his/her preference. Despite this, it is recognized that planned that they were withdrawn from the study. In
lack of tolerance and lack of adherence to daily phy- the event, this did not happen to any patient.
siotherapy exists irrespective of the method used.17 All methods of treatment were carried out with the
Hydro acoustic therapy (HAT) is a novel method in patients sitting in the same HAT bath in order to
which sound waves are externally delivered onto the account for the effect of water humidity on sputum
chest wall of patients while immersed in bath water. production. Three methods of treatment were com-
The treatment is relatively passive with the patient pared—HAT, flutter valve and placebo. The order
simply sitting in a bath of warm water while being of methods was randomized.
exposed to water-borne sound waves delivered to the Patients were asked to take their medications in the
chest wall. The procedure can be self-administered usual manner. They were asked not to perform their
and the equipment is relatively inexpensive. Prelimi- morning physiotherapy prior to treatment sessions.
nary tests showed HAT to be well tolerated and more They were asked to collect, in a separate pot each day,
effective in terms of the weight of expectorated spu- the morning sputum produced with cough for the 2
tum than the VEST. Comparison with the VEST in days prior to visit one. The weight of daily wet and
this study was made as it is a device that works to dry sputum was used as a baseline.
clear sputum in a similar method to HAT, using an The bath measured 240 cm in length, 170 cm in
external vibratory source to dislodge sputum from air- width and 170 cm in height. It was equipped with a
way walls. In this study, efficacy was assessed as the water-sealed door. Patients undergoing HAT were
weight of dry sputum produced18 but not lung func- submerged underwater to the neck level. The bath
tion tests. Patients’ preference was not sought. The has an on/off switch button which the patient can
bath used in this comparison was large, cumbersome press (Figure 1). The acoustic waves were delivered
and was not fit to be commercially distributed. from two sound sources placed at each sides of the
A new and smaller version of the HAT bath has bath at the patients’ chest wall level. The amplitude
been developed. This provided an opportunity to of the sound was set at 158 dB re 1 micro Pascal.
examine the efficacy and tolerability of this technique Three frequencies were delivered each for 10 min-
and to compare it to other methods of physiotherapy. utes: the Helmholtz resonance frequency of the
This is the purpose of this study. lungs (at 20 Hz), the measured ‘breathing mode’
resonance frequency (at 40 Hz) and an intermediate
frequency (at 30 Hz). This was based on previous
Patients and methods experience in which it is found that this treatment
The study was approved by the Central and South regimen was safe and most effective.19,20 This fre-
Bristol Research Ethics Committee, reference num- quency is similar to that used in the external vibrat-
ber: E5805. ing device (the VEST) and higher than devices that
Inclusion criteria were CF patients with daily spu- apply vibration through the airways such as positive
tum production, age over 16 years, forced expiratory expiratory pressure valve.
Jarad et al. 219
Table 2. Median and inter-quartile comparisons of weight of the sputum in the 2 study days for each method used in this
triala
Wet sputum Dry sputum
n Day 1 Day 2 Day 1 Day 2
Morning collection 13
Median 3.5 1.5 0.50 0.35
25% percentile 1.08 0.44 0.35 0.27
75% percentile 5.1 1.5 1.11 0.75
HAT 18
Median 0.86 1.83 0.02 0.05
25% percentile 0 0 0 0
75% percentile 8.3 6.6 0.31 0.33
Flutter 18
Median 0.66 0 0.03 0
25% percentile 0 0 0 0
75% percentile 5.6 7.6 0.27 0.42
Placebo 18
Median 2.83 2.15 0.06 0.05
25% percentile 0 0 0 0
75% percentile 6.33 5.95 0.3 0.29
HAT: hydro-acoustic therapy.
a
p Value was not significant for all comparisons performed using the Wilcoxon’s matched pair tests.
Table 3. Median and 25% and 75% percentile for the total weight of wet and dry sputum for all the methods over 2 daysa
n Wet sputum Dry sputum
Morning collection 26
Median 2.16 0.41
25% percentile–75% percentile 0.85–5.4 0.29–0.89
HAT 36
Median 1.02 0.02
25% percentile–75% percentile 0.0–6.6 0–0.28
Flutter 36
Median 0.57 0.01
25% percentile–75% percentile 0–5.3 0–0.27
Placebo 36
Median 2.8 0.05
25% percentile–75% percentile 0–5.1 0–0.28
HAT: hydro-acoustic therapy, N: number of treatments.
a
The weight of sputum during morning collection was greater than those produced by any methods (p < 0.001 for all methods). p Values
were not significant for any comparison for any of the three treatment arms. Mann-Whitney U test was used in this comparison.
Table 4. Lung function tests in the 2 study days before and after each type of treatmenta
HAT Flutter Placebo
Day 1 Day 2 Day 1 Day 2 Day 1 Day 2
FEV1
Before 1.82 (0.64) 1.87 (0.71) 1.89 (0.73) 1.83 (0.71) 1.76 (0.58) 1.79 (0.65)
After 1.75 (0.64) 1.79 (0.68) 1.85 (0.72) 1.79 (0.69) 1.75 (0.62) 1.77 (0.67)
FVC
Before 2.98 (0.87) 3.10 (0.8) 3.20 (0.94) 3.16 (0.89) 3.11 (0.80) 3.11 (0.83)
After 2.85 (0.79) 3.00 (0.85) 3.17 (0.86) 3.12 (0.89) 3.06 (0.82) 3.05 (0.87)
FEF 75%
Before 2.84 (1.76) 2.87 (2.21) 2.84 (1.96) 2.75 (1.89) 2.43 (1.44) 2.73 (1.84)
After 2.68 (1.96) 2.64 (1.92) 2.75 (1.89) 2.89 (2.19) 2.46 (1.55) 2.66 (1.89)
FEF 25–75
Before 2.31 (1.61) 2.39 (1.94) 2.37 (1.69) 2.42 (1.94) 2.0 (1.33) 2.15 (1.72)
After 2.18 (1.63) 2.11 (1.73) 2.31 (1.60) 2.28 (1.82) 2.0 (1.40) 2.15 (1.58)
FEV1: forced expiratory volume in the first second, FVC: forced vital capacity, FEF 75: forced expiratory flow at 75% of vital capacity,
FEF 25–75: forced expiratory flow between 25% and 75% of vital capacity, HAT: hydro-acoustic therapy.
a
The values prior to treatment were similar for all study arms (two tailed t test) and did not differ in the 2 study days for all methods
(paired t test). This suggests that the decline in some lung function values after treatment had recovered by the following day (see also
Table 5 and text).
Table 5. Change in lung function parameter before and after each type of treatmenta
HAT Flutter Placebo
FEV1 (litre)
Pre-treatment 1.86 (0.66) 1.86 (0.71) 1.78 (0.61)
Post-treatment 1.78 (0.64) 1.82 (0.70) 1.76 (0.63)
p value 0.001 0.028 0.133
FVC (litre)
Pre-treatment 3.01 (0.82) 3.19 (0.91) 3.11 (0.8)
Post-treatment 2.92 (0.79) 3.15 (0.83) 3.01 (0.83)
p Value 0.041 0.30 0.77
FEF 75 (litre/second)
Pre-treatment 2.89 (1.93) 2.86 (2.04) 2.58 (1.63)
Post-treatment 2.68 (1.87) 2.73 (1.95) 2.56 (1.71)
p Value 0.07 0.007 0.43
FEF 25–75 (litre/second)
Pre-treatment 2.37 (1.72) 2.40 (1.76) 2.00 (1.31)
Post-treatment 2.16 (1.63) 2.29 (1.69) 2.01 (1.48)
p Value 0.048 0.03 0.90
FEV1: forced expiratory volume in the first second, FVC: forced vital capacity, FEF 75: forced expiratory flow at 75% of vital capacity,
FEF 25–75: forced expiratory flow between 25% and 75% of vital capacity, HAT: hydro-acoustic therapy.
a
Data are expressed as mean (SD) and compared using paired t test.
Table 6. The questionnaire administered after the last of the six sessionsa
Q1. Regarding your breathlessness, HAT is:
much worse than the physiotherapy technique that you used to do 0%
Slightly worse than the physiotherapy technique that you used to do 17.6%
similar than the physiotherapy technique that you used to do 35.3%
Slightly better than the physiotherapy technique that you used to do 23.5%
much better than the physiotherapy technique that you used to do 23.5%
Q2. Regarding your breathlessness, HAT is:
much worse than the flutter device 0%
Slightly worse than the flutter device 5.9%
similar than the flutter device 29.4%
Slightly better than the flutter device 29.4%
much better than the flutter device 35.3%
Q3. Regarding your breathlessness, placebo is:
much worse than the flutter device 0%
Slightly worse than the flutter device 11.8%
similar than the flutter device 23.5%
Slightly better than the flutter device 41.2%
much better than the flutter device 23.5%
Q4. Regarding your breathlessness, placebo is:
much worse than HAT 0%
Slightly worse than HAT 23.5%
similar to HAT 52.9%
Slightly better than HAT 17.6%
much better than HAT 5.9%
Q5. Regarding the ease by which phlegm is coughed up, HAT is:
much worse than the physiotherapy technique that you used to do 0%
Slightly worse than the physiotherapy technique that you used to do 18.8%
similar than the physiotherapy technique that you used to do 43.8%
Slightly better than the physiotherapy technique that you used to do 31.3%
much better than the physiotherapy technique that you used to do 6.3%
Q6. Regards to the ease by which the phlegm is coughed up, HAT is:
much worse than the flutter device 0%
Slightly worse than the flutter device 12.5%
similar to the flutter device 25.0%
slightly better than the flutter device 31.3%
much better than the flutter device 31.3%
Q7. Regards to the ease by which the phlegm is coughed up, placebo is
much worse than the flutter device 6.3%
slightly worse than the flutter device 25.0%
similar to the flutter device 37.5%
slightly better than the flutter device 18.8%
much better than the flutter device 12.5%
Q8. Regards to ease by which the phlegm is coughed up, placebo is
much worse than HAT 12.5%
slightly worse than HAT 25.0%
similar to HAT 50.0%
slightly better than HAT 0%
much better than HAT 12.5%
(continued)
224 Chronic Respiratory Disease 7(4)
Table 6 (continued)
Q9. Regards to relaxation, HAT is:
much worse than the flutter device 0%
slightly worse than the flutter device 11.8%
similar to the flutter device 0%
slightly better than the flutter device 17.6%
much better than the flutter device 70.6%
Q10. Regards to relaxation, placebo is:
much worse than the flutter device 0%
slightly worse than the flutter device 0%
similar to the flutter device 11.8%
slightly better than the flutter device 23.5%
much better than the flutter device 64.7%
Q11. Regards to relaxation, placebo is:
much worse than HAT 0%
slightly worse than HAT 18.8%
similar to HAT 50.0%
slightly better than HAT 31.3%
much better than HAT 0%
Q12. Overall I found the HAT therapy
Very unpleasant 0%
Slightly unpleasant 17.6%
OK 23.5%
Slightly pleasant 17.6%
Very pleasant 41.2%
Q13. Overall I found the Flutter therapy
Very unpleasant 11.8%
Slightly unpleasant 23.5%
OK 64.7%
Slightly pleasant 0%
Very pleasant 0%
Q14. Overall I found the placebo therapy
Very unpleasant 0%
Slightly unpleasant 5.9%
OK 35.3%
Slightly pleasant 17.6%
Very pleasant 41.2%
Q15. If available I would prefer for physiotherapy
My usual physiotherapy technique 29.4%
Physiotherapy using HAT 70.6%
Physiotherapy using EST 0%
Physiotherapy using the flutter device 0%
HAT: hydro-acoustic therapy.
a
The proportion of patients who chose each item of the questionnaire is outlined on the right. Patients were not told which trial they
received HAT or placebo until after the last trial session. Flutter was used while patients’ were sitting in the bath.
produced, breathlessness during physiotherapy and described previously. The weight of the morning spu-
relaxation. tum produced by patients was found to be similar over
Our study demonstrated several other aspects of 2 successive days, which would suggest that the
sputum production in CF patients, which were not amount of sputum produced is probably similar on a
Jarad et al. 225
patients. It is envisaged that HAT may be used to 6. Jarad NA, Giles K. Risk factors for increased need for
deliver at least one of the two daily physiotherapy intravenous antibiotics for pulmonary exacerbations in
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HAT session could be combined with other morning 2008; 5: 1–5.
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We have not investigated the value of HAT during 8. Nelson R, Miller S, Hall D, and Clayton B. Chest
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Nedwell for their assistance in constructing the Bath and 11. Elkins M, Jones A, and van der Schans CP. Positive
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The authors had no conflicts of interest.
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