Chest
Volume 114, Issue 4, October 1998, Pages 993-997
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Clinical Investigations: Cystic Fibrosis
Comparison of the Flutter Device to Standard Chest Physiotherapy in Hospitalized Patients With Cystic Fibrosis: A Pilot Study

https://doi.org/10.1378/chest.114.4.993Get rights and content

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.

Design

Open label, comparative trial with alternate assignment.

Setting

Community and childrens’ hospital acute-care wards.

Participants

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

Interventions

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 α = 0.05, a sample of 219 subjects in each group would be necessary.

Summary

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.

Section snippets

The Device

The flutter (Scandipharm; Birmingham, AL) is Food and Drug Administration approved for airway clearance. It is a pipe-like device with a mouthpiece, an oscillating stainless steel ball, and a perforated cover. Air flows through the device from the mouthpiece through the perforated cover causing oscillation of the steel ball with production of rhythmic variations in positive expiratory pressure of about 10 to 25 cm H2O. Proposed mechanisms of effect include shearing of mucus from airway wall by

RESULTS

Baseline demographics, PFT data, mean length of hospitalization, and mean number of respiratory treatments received during the hospitalization did not differ significantly between the flutter and CPT groups (Table 2). Average percent change in clinical score (CS) and PFT results from baseline (admission) to discharge showed significant improvements with either CPT or flutter in all PFT parameters studied except TLC for flutter and TLC and FEV1/FVC for CPT (Table 3). Average percent change from

DISCUSSION

Standard, manual chest percussion has been the “gold standard” for airway clearance in CF patients for many decades. This therapy has been shown to be effective but requires a helper to administer, is time consuming, and is potentially traumatic.18 Compliance with this important therapy is not likely, especially in the case of the independent functioning older CF patient.19, 20 Additionally, this type of therapy is labor intensive in the hospital setting requiring one-on-one attendance by

ACKNOWLEDGMENTS

The authors would like to acknowledge the invaluable help of the Respiratory Care Department of Bronson Methodist Hospital, Dr. Michael Stoline, Department of Mathematics and Statistics, Western Michigan University, Chrysanthe Fooy, RN, MSN, MSU/KCMS, Research Nurse, and our dedicated CF patients and families.

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  • Cited by (0)

    Supported by the MSU/KCMS CF Center Grant

    Presented in part at the 10th Annual North American Cystic Fibrosis Conference, Orlando, FL, October 24–27, 1996

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