Airway clearance in cystic fibrosis patients is an important component of the total treatment of CF. In the U.S., postural drainage with clapping and vibration have been the standard therapy. Now the Flutter, a new chest physiotherapy device recently granted market clearance by the Food and Drug Administration, seems to hold promise as an easier and more effective means of accomplishing this vital therapy.
The Flutter was invented by a Swiss physiotherapist, Patrick Althaus, as a method for loosening mucus in the airways; CF patients in other countries have been using the Flutter since mid-1989. The patient breathes through the Flutter against resistance, which is generated by blowing a small stainless ball upward inside a cone at the of a pipe-shaped device. The ball covers the opening of the cone; as it vibrates within the cone, it keeps pressure in the bronchi high during expiration and thus the bronchi remain open. When breathing out against the pressure of the ball, it also produces low-frequency vibration impulses that ease the transport of the mucus secretions.
The Flutter is being distributed in the U.S. exclusively by Scandipharm. Scandipharm markets a comprehensive line of products specifically for the management of cystic fibrosis. The device was developed in Switzerland and is used there extensively for cystic fibrosis as well as for other chronic obstructive pulmonary diseases. According to the Swiss manufacturer, VarioRaw SA, the Flutter is a "new personal therapeutic device designed to help mucus elimination and hence, improve bronchial clearance. Furthermore, it is easy, safe, and without side-effects. In short, the Flutter helps expectorate mucus better."
The Flutter will make its debut in the United States sometime this summer. Doctors at Rainbow Babies and Childrens Hospital, Cleveland, Ohio became aware of the device several years ago when a patient from Europe, who used it regularly, began to receive his care at Rainbow while attending college in the U.S.
Jim Bolek, a respiratory therapist, and the CF physicians at Rainbow began to work with VarioRaw in an effort to get the Flutter approved by the FDA for use in the U.S. This required a study to show that use of the Flutter was effective in removing mucus from the lungs of CF patients. Rainbow compared the amount of mucus raised by the Flutter to that raised by postural drainage and cough alone and found that the Flutter was over three times more effective than postural drainage. Their results were published in the May 1994 issue of theJournal of Pediatrics (Konstan et al).
Dr. Karen Hardy, at the Chief Pediatric Pulmonary and Cystic Fibrosis Center, California Pacific Medical Center noted that, "The Flutter is a handheld pipe-like device that causes positive expiratory pressure and airway oscillations. It combines PEP and airway oscillations, which explains the increased sputum production seen in the Rainbow Study." According to Dr. John Marks, a colleague of Dr. Hardy, the "Flutter is one more thing that may be helpful to CF patients. It is not a major advance, but it is definitely a way some patients can efficiently and independently do airway clearance." Like Dr. Hardy, Dr. Marks also thinks more clinical studies are needed to demonstrate the Flutter's effectiveness.
Barbara Palys, President of the International Association of Cystic Fibrosis Adults (IACFA), has used the Flutter for two years and likes the independence and convenience. "I can carry it everywhere. It simply works wonderfully!"
Achieving optimal results with the Flutter depends upon the patient's ability to properly utilize the device. Jim Bolek begins training patients at about four or five years of age. "However, the extent of supervision should diminish once the child becomes proficient," he said. "Furthermore, patients/caregivers need to be taught how to assess airway clearance techniques and should learn how to determine when the airways are clean," he added.
Will U.S. insurance companies accept the Flutter? Hopefully, once the benefit is justified through further research, the insurance companies will accept it. The Flutter is inexpensive and, according to the study, "It could improve patient compliance with mucus-clearance therapy and result in reduced costs of care."
In conclusion, CF patients should consult with their physicians and respiratory therapists to determine what treatment is best for them. The Flutter is a prescription device and must be obtained from your physician. For further information on the Flutter, please contact Scandipharm, 22 Inverness Center Parkway, Birmingham , Alabama 35242. Or call (800) 950 - 8085.
Reprinted with permission of the IACFA Newsletter.
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