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Trial registered on ANZCTR


Registration number
ACTRN12614001072606
Ethics application status
Approved
Date submitted
25/09/2014
Date registered
7/10/2014
Date last updated
7/10/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the ease of secretion clearance with flutter device compared to lung FLute in patients with Bronchiectasis
Scientific title
Evaluating sputum clearance in bronchiectasis patients using Flutter device or Lung Flute
Secondary ID [1] 285399 0
Nil Known
Universal Trial Number (UTN)
U1111-1162-2146
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiectasis 293139 0
Condition category
Condition code
Respiratory 293408 293408 0 0
Other respiratory disorders / diseases
Physical Medicine / Rehabilitation 293458 293458 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Bronchiectasis outpatients will be randomised to which order they will use the FLutter or Lung FLute. They will attend two sessions one week apart at the same time. During the first session if they used the Flutter then second session a week away they will use the Lung Flute or vice versa depending which device they use first on the randomisation. Both sessions when using the FLutter and Lung Flute they will be supervised by a physiotherapist. Each session will last one hour. The same physiotherapist will be supervise both sessions of all the patients.

Lung Flute is a new device which has been shown to improve secretions on patients with Chronic obstructive airway disease. Lung Flute will be the intervention device to see its effectiveness in clearing secretions on patients with Bronchiectasis. The instructions were as per manufacturers guidelines. Patients were instructed to sit up straight so that their back was not touching the back of the chair. Patients were asked to hold the lung flute pointing it down. They were asked to inhale a little deeper than normal, then place their lips completely around the mouthpiece, and gently blow out through the Lung FLute as if trying to blow out a candle. As they blew out the patients were asked to concentrate on making the reed inside move and make a fluttering noise. At the end of the exhaled breath they were asked to remove the lung flute from the mouth and take a breath in and blow out again to the lung Flute in a similar manner. After 2 blows the patients were instructed to remove the device and wait 5 seconds, taking several normal breaths. Then repeat. Patients were asked to do 20 sets of 2 blows each unless the patient felt lightheaded or fatigued. If the patient could not tolerate the number of sets the technique would be modified to do fewer sets. At the end of the session the patients were asked to wait five minutes for secretions to collect to the back of their throat then do mid and low volume huff and when the secretions were in the oropharynx to do a high volume huff or cough to clear secretions. The average time to complete using the lung flute would be 5-10 minutes. This would be the end point of this technique. Then patients would be asked to wait another 30 minutes and sputum would be collected until this time. The overall duration of this session would last about one hour (this includes from when the patient comes in to use the Lung Flute, time taken to use the Lung Flute and then staying for 30 miinutes).

The sputum during the session (lasting 5-10 minutes) until end point and from this point sputum cleared up to 30 minutes will be collected. The sputum will be weighed and then will be dried in a microwave oven 300 Watts for 10 minutes and reweighed to get the dry weight of sputum.
Intervention code [1] 290316 0
Treatment: Devices
Comparator / control treatment
Flutter is a device which has shown to assist secretion clearance in Bronchiectasis. It was administered as per manufactures guidelines. The pateints were instructed to sit with the back with the head tilted slightly upward so that the throat and windpipe are open. If they had difficulty they were allowed to place the elbows on a table at a height so the patients did not slouch. An adjustable bed was used for this purpose. The patient would be instructed to inhale deeply and hold his/her breath for 2-3 seconds. Then the patient would be instructed to place the mouthpiece of the device into the mouth and exhale into expiratory reserve volume (ie, slightly further than one would exhale during normal breath but not to residual volume). During expiration through the flutter, the patient would be instructed to tilt the flutter upwards and downwards by a few degrees to induce maximum oscillations within the chest wall. They were also instructed to keep the cheeks stiff and if they could not do it they were allowed to hold the cheeks flat with the other hand. This would be repeated for 10 breaths, with the patient inhaling through the nose and exhaling through the flutter. Then the patients would be performing one or two mid to low volumes huffs combined with periods of breathing control (normal tidal breathing). If the patients felt that they had cleared the secretions to the oropharynx then they would be instructed to do a high volume huff or cough to clear the secretions. Then the cycle was repeated after clearing secretions or if there was no secretions to clear from the oropharynx, after the low volume huff. The duration of periods of breathing control was varied depending on patients, the time required for patients to regain their normal breathing pattern and fatigue. The patients would be allowed to cough as required. The end point of the technique would be defined as two cycles and dry sounding huff. The average time to exhale in to the flutter would last 5-10 minutes. If the defined end point was not achieved within 30 minutes, the session was judged complete. From this end point patients would be asked to wait for 30 minutes and sputum cleared would be collected. The overall duration of this session would last about one hour (this includes from when the patient comes in to use the flutter, time taken to use the flutter and then staying for 30 miinutes).
Control group
Active

Outcomes
Primary outcome [1] 293236 0
The total amount of sputum collected is the amout of sputum collected when using the devices lasting 5-10 minutes untill the end point plus from that end point during and up to 30 mintues after was defined as total wet sputum.


This sputum would be weighed using a "A and D" HL-i Digital Compact Scale (accurate to 200 x 0.1g) will be used for all weights. A pre-weighed cup will be given to each patient and the cup and sputum contents will be re weighed to calcuate the "wet weight of sputum".
Timepoint [1] 293236 0
The total amount of sputum collected (during treatement until end point and then up to 30 minutes after from end point)
Primary outcome [2] 293295 0
From the total wet sputum will then be dired in a mocrowave oven (300Watts for 10 minutes) and re-weighed to calculate the dry weight of sputum.

Timepoint [2] 293295 0
The total amount of sputum collected (during treatement until end point and then up to 30 minutes after end point)
Secondary outcome [1] 310651 0
Likert scale to assess acceptability and tolerability of the devices. This is one scale with 8 questions. Thus only one secondary outcome measure.
The 8 questions had a rating scale of 1-7 (strogly disagree to strongly agree).
The 8 questions were
1. Assisted you with clearing secretions
2. It was easy to understand instructions
3. It was simple to use
4. The device made me tired
5. The device caused discomfort to use
6. Using the device is time consuming
7. Using the device would interfere with your everyday life
8. Using the device would cause embarrassment
Timepoint [1] 310651 0
At the end of each treament they will fill up a Likert Scale for each treament.

Eligibility
Key inclusion criteria
Diagnosis of non cystic fibrosis Bronchiectasis (diagnosed on high resolution computerised tomography) who should produce greater than 25ml of sputum per day.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current pneumothorax, untreated cor pulmonale, Haemoptysis, patients with an exacerbation from baseline (defined as a sustained increase in sputum purulence or volume over three or more day in the 4 weeks prior or during the study that required medical intervention and prescription of antibioitics) or if they were hospitalised during the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3016 0
Concord Repatriation Hospital - Concord

Funding & Sponsors
Funding source category [1] 290006 0
Commercial sector/Industry
Name [1] 290006 0
Niche Medical
Address [1] 290006 0
PO Box 1737
North Sydney
NSW 2059
Country [1] 290006 0
Australia
Primary sponsor type
Individual
Name
Yasmin Silva
Address
Physiotherapy Department
Concord Repatriation General Hospital
Hospital Road
COncord NSW 2139
Country
Australia
Secondary sponsor category [1] 288690 0
Hospital
Name [1] 288690 0
Respiratory Department, Concord Repatriation General Hospital
Address [1] 288690 0
Hospital Road, Concord, NSW 2139
Country [1] 288690 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291712 0
Concord Hospital Ethics and Reseach
Ethics committee address [1] 291712 0
Hospital Road, Concord, NSW, 2139
Ethics committee country [1] 291712 0
Australia
Date submitted for ethics approval [1] 291712 0
17/10/2012
Approval date [1] 291712 0
29/11/2012
Ethics approval number [1] 291712 0
LNR/12/CRGH/188

Summary
Brief summary
Bronchiectasis is pathological condition with diverse aetiologies, characterised by and abnormal dilation of conducting airways due to repeated cycles of airway infection and inflammation ultimately resulting in airway and lung parenchyma destruction. This leads to an alteration of the ciliated epithelial lining and compromises mucus clearance. In the affected areas there is excess production of mucus, where the impaired clearance of secretions causes colonisation and infections. Airway clearance techniques are regarded as an integral component in the management of Bronchiectasis, as it clears blockages of conducting airway and improves pulmonary ventilation. Some patients with Bronchiectasis only have scant secretions and it is unclear if airway clearance assists them. A systemic review on patients with chronic obstructive pulmonary disease, has reported airway clearance techniques to be useful only in patients who produce greater than 25 ml (one tablespoon) of sputum per day.

Mechanical forms of airway clearance such as Flutter (Scandipharm Inc, Birmingham, Alabama, USA) has shown to assist with secretion clearance. Flutter is a simple hand held pipe like device which produces oscillating positive pressure on exhalation, through repeated displacement of the steel ball within a cone. Oscillation frequency within 3-17 Hz range has been shown to facilitate mucociliary clearance. On patients with cystic fibrosis (CF), the flutter demonstrated a mean oscillation frequency of 11.3 Hz 5. This was close to this optimal frequency range to facilitate mucociliary clearance. This study also demonstrated the Flutter to have a peak expiratory flow rate (PEFR) / peak inspiratory flow rate (PIFR) ratio > 1.1, which is critical level required for annular flow of secretions towards the oropharynx. In addition flutter has shown to alter physical properties of mucus in patients with Bronchiectasis which further assist secretion clearance.

Lung Flute (Medical Acoustics, LLC, Buffalo, NY USA) is new device which has shown to assist secretion clearance. It is relatively cheaper than the Flutter. The current literature on the efficacy of the lung Flute is limited. The lung flute is a hand held device shaped like a flute with a mouth piece and a reed inside it. When the user blows into the lung flute, it creates a specific low frequency sound. The manufactures claim that this sound generates 18-22Hz with an output of 110 to 115 dB using 2.5 cmH2O pressure. This sound wave, when generated at the mouth with mild exhalation, is thought to travel retrograde down the tracheobronchial tress and vibrates the tracheobronchial secretions. The manufactures claim that this sound vibrates the airways and thins the lung secretions, which facilitate mucocilary clearance. Lung flute has demonstrated to expectorate similar quantity of sputum as active cycle breathing technique in patients with Bronchiectasis. No study has been done to evaluate the effectiveness lung flute compared to the Flutter. Therefore, the aim of the current study was to evaluate if the lung flue was as effective as the flutter in secretion clearance.

Method.
Study design:
After ethics approval participants were recruited from the Bronchiestasis clinic at CRGH and any person with bronchiectasis referred for physiotherapy from other respiratory specialists. During the study patients were seen as outpatients.

Inclusion criteria: patients with productive non – cystic fibrosis (CF) bronchiectasis (diagnosed on high resolution computerised tomography) who would produce greater than 25ml of sputum per day.

Exclusion criteria: current pneumothorax, untreated cor pulmonale, haemoptysis, patients with an exacerbation in the 4 weeks prior or during the study and if they were hospitalised during the study.

Information sheet about the study would be given to the participant and informed consent would be obtained.
Patients would attend two visits over a two week period standardised to the same time of day, with advice to withhold usual airway clearance 24 hours prior to attendance. At each session one of the following airway clearance techniques (flutter, lung flute) will be performed in random order determined by computer generated randomisation with concealed allocation. Patients would receive comprehensive standardised practical instructions in each airway clearance technique. Participants would be supervised throughout by an experienced senior respiratory physiotherapist to ensure each technique was performed in a standardised and optimal manner. Duration of treatment would be recorded. Baseline medications were not altered.

Treatment techniques
Both treatment techniques would be performed in sitting. Patients would be instructed to clear secretions without to swallow the sputum.

Flutter
The patient would be instructed to inhale deeply and hold his/her breath for 2-3 seconds. Then the patient would be instructed to place the mouthpiece of the device into the mouth and exhale into expiratory reserve volume (ie, slightly further than one would exhale during normal breath but not to residual volume). During expiration through the flutter, the patient would be instructed to tilt the flutter upwards and downwards by a few degrees to induce maximum oscillations within the chest wall. This would be repeated for 10 breaths, with the patient inhaling through the nose and exhaling through the flutter. Then the patients would be performing one or two mid to low volumes huffs combined with periods of breathing control (normal tidal breathing). If the patients felt that they had cleared the secretions to the oropharynx then they would be instructed to do a high volume huff or cough to clear the secretions. Then the cycle was repeated after clearing secretions or if there was no secretions to clear from the oropharynx, after the low volume huff. The duration of periods of breathing control was varied depending on patients, the time required for patients to regain their normal breathing pattern and fatigue. The patients would be allowed to cough as required. The end point of the technique would be defined as two cycles and dry sounding huff. If the defined end point was not achieved within 30 minutes, the session was judged complete.

Lung Flute
The patients would be instructed to inhale slowly slightly deeper than normal and then place the mouthpiece of the device into the mouth. Then hold the lung flute pointing down at an angle and blow gently into the lung flute as if trying to blow out a candle. As they blow into the lung flute they would hear the reel inside the horn making a fluttering noise as it moves. Instruct the patient to concentrate on making more noise by blowing harder and faster into the lung flute. After blowing into the lung Flute twice, patients would be instructed to remove the mouth piece and wait for five seconds, taking several normal breaths. Then repeat this whole cycle of 20 sets with two blows each, unless the patient feels lightheaded or fatigued. If the patient was unable to tolerate the number of sets, the technique would be modified to do fewer sets. At the end of the session patients would be instructed to wait for 5 minutes and then do a low to mid volume huff , and when the secretions are in the oropharynx to to do a high volume huff or cough to clear the secretions. The average session would for 5 -10 minutes. This would be the end point of this technique.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51690 0
Ms Yasmin Silva
Address 51690 0
Physiotherapy Department,
Concord Repatriation General Hospital
Hospital Road, Concord, NSW, 2139
Country 51690 0
Australia
Phone 51690 0
+61297676101
Fax 51690 0
Email 51690 0
yasmin.silva@sswahs.nsw.gov.au
Contact person for public queries
Name 51691 0
Ms Yasmin Silva
Address 51691 0
Physiotherapy Department, Concord Repatriation General Hosptial,Hospital Road, Concord, NSW, 2139
Country 51691 0
Australia
Phone 51691 0
+61297676101
Fax 51691 0
Email 51691 0
yasmin.silva@sswahs.nsw.gov.au
Contact person for scientific queries
Name 51692 0
Dr Lucy Morgan
Address 51692 0
Respiratory Medicine 7 West, Concord Repatriation General Hosptial, Hospital Road, Concord, NSW, 2139
Country 51692 0
Australia
Phone 51692 0
+61297676712
Fax 51692 0
Email 51692 0
lucy.morgan@sswahs.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
No Results