Clinical Study Results; Directions For Use - Aptalis Flutter Mucus Clearance Device Instructions For Use

CLINICAL STUDY RESULTS

Cystic Fibrosis, Bronchitis and Bronchiectasis are characterized by abnormally thick mucus.
Inhaled bacteria can become imbedded in these secretions, resulting in inflammation which
leads to destructive disease of the lungs.
The efficacy of the FLUTTER
reported. The average amount of sputum expectorated with the FLUTTER
the amount expectorated after conventional postural drainage with percussion and vibration.
Every patient expectorated more mucus with the FLUTTER
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drainage.

DIRECTIONS FOR USE

The patient should be seated with back straight and head slightly tilted upward so the upper
airway is wide open (Figure 5). This will allow exhaled air to flow smoothly from the lungs and
out through the FLUTTER
on a table at a comfortable level and head position as described above.
The angle at which the patient holds the FLUTTER
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FLUTTER should be held so that the stem is horizontal to the floor, which places the cone at a
slight tilt. The tilt insures that the ball not only bounces but also rolls during exhalation. This
combined rolling and bouncing of the steel ball produces the vibrations that dislodge mucus
from the airways. The FLUTTER
resonance frequency, which is done by moving the FLUTTER
the maximum "fluttering" effect (Figure 7). This resonance is evidenced by the vibrations within
the chest that can be felt by the patients. The healthcare professional can help determine if the
patient has achieved the "fluttering" effect by placing one hand on the patient's back and the
other hand on the patient's chest. The vibrations in the lungs can be felt as the patient exhales.
After the patient has established a comfortable position and selected the proper tilt to maximize
"fluttering," therapy may begin.
Beginning with Stage 1 - Mucus Loosening and Mucus Mobilization. Instruct the patient to
slowly inhale to approximately 3/4 of a full breath. Place the FLUTTER
closed firmly around the stem. Position the FLUTTER
second breath-hold. This allows the inhaled air to be evenly distributed throughout the lungs.
Now the patient should exhale through the FLUTTER
speed. During the exhalation, keep the cheeks stiff, so the vibrations produced by the
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FLUTTER are not wasted in the cheeks. Have the patient concentrate on feeling the airways
vibrate and continue to exhale through the FLUTTER
exhale during normal breathing without the FLUTTER
be suppressed. Have the patient repeat this breathing technique for another 5 to 10 breaths to
loosen and mobilize as much mucus as possible. The mucus moves farther up the airways with
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each FLUTTER exhalation. Emphasize to the patient the importance of inhaling slowly, holding
the breath 2 to 3 seconds, and suppressing the urge to cough.
Now the patient is ready to begin Stage 2 - Mucus Elimination. Have the patient perform 1
or 2 additional breaths through the FLUTTER
comfortably possible. Really fill the lungs with air. Again perform a 2 to 3 second breath-hold.
Now, have the patient exhale forcefully through the FLUTTER
comfortably as possible. This forceful exhalation moves mucus up to a level in the lungs that
triggers a cough. However, if the mucus is not easily coughed out following 1 or 2 elimination
breaths, the patient should attempt a "huff" maneuver (like trying to "huff" a bread crumb out of
the throat).
The standard series of 5 to 10 mucus-loosening breaths with cough suppression followed by 1
or 2 mucus elimination breaths with cough should result in successful airway clearance. If your
patient is new to FLUTTER
repetitions of Stage 1, Mucus Loosening and Mucus Mobilization, before performing Stage 2,
Mucus Elimination. Several trials may be necessary to determine the appropriate number of
breaths needed in each stage for individual patients.
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in facilitating mucus clearance in Cystic Fibrosis has been
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. As an alternative, the patient may be seated with elbows resting
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then needs to be adjusted to the patient's pulmonary
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. This time, breathe in slowly and as fully as
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therapy or has particularly thick mucus, it may take multiple
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was over four times
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than with conventional postural
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is critical (Figure 6). Initially, the
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slightly up or down to achieve
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in the mouth with lips
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at the proper angle and perform a 2 to 3
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at a reasonably fast but not too forceful
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to a level slightly further than one would
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. At this point the urge to cough should
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as completely and as