Comparison of the flutter device to standard chest physiotherapy in hospitalized patients with cystic fibrosis: a pilot study.
OBJECTIVE
A preliminary study comparing the efficacy and safety of the flutter device (Flutter) to standard, manual chest physiotherapy (CPT) in hospitalized cystic fibrosis (CF) patients undergoing an acute pulmonary exacerbation.


METHODS
Open label, comparative trial with alternate assignment.


METHODS
Community and childrens' hospital acute-care wards.


METHODS
Twenty-two CF patients (ages 8 to 44 years) undergoing a total of 33 hospitalizations for acute pulmonary exacerbation.


METHODS
Complete pulmonary function tests (PFTs) were done at baseline (admission), weekly, and upon discharge from the hospital. Clinical score (CS) was determined at the time of hospital admission and at discharge. Participants were assigned to receive supervised Flutter therapy or standard, manual CPT four times per day during the hospitalization. Patients were monitored for complications, including hemoptysis, hypoxemia, and pneumothorax.


RESULTS
The groups (CPT and Flutter) did not differ at baseline in demographics or Shwachman score, nor was length of hospitalization different. Significant improvements were noted from admission to discharge in CS and PFT results within each group. Mean percent change in CS and PFT results between CPT and Flutter groups showed no significant difference from hospital admission to discharge. Subsequent power analysis using the observed difference in percent change from admission to discharge for FEV1 indicated that to attain 80% power at alpha = 0.05, a sample of 219 subjects in each group would be necessary.


CONCLUSIONS
Comparative trials of airway clearance techniques with sufficient sample size are lacking. Although the Flutter appears to be a useful device for independent, cost-effective, and safe administration of CPT in this pilot study, a much larger clinical trial would be necessary to make definitive conclusions.
Homnick
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DN
Michigan State University, Kalamazoo Center for Medical Studies, 49008, USA. homnick@kcms.msu.edu
Anderson
K
K
Marks
J H
JH
D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D002648:Child; D003550:Cystic Fibrosis / Q000503:physiopathology / Q000534:rehabilitation*; D015916:Drainage, Postural / Q000295:instrumentation*; D005260:Female; D005500:Follow-Up Studies; D006760:Hospitalization; D006801:Humans; D007902:Length of Stay; D008297:Male; D010865:Pilot Projects; D011446:Prospective Studies; D012129:Respiratory Function Tests; D012138:Respiratory Therapy / Q000295:instrumentation*; D012449:Safety; D016896:Treatment Outcome