COMPARISON OF THE FLUTTER DEVICE TO STANDARD CHEST PHYSIOTHERAPY IN HOSPITALIZED-PATIENTS WITH CYSTIC-FIBROSIS - A PILOT-STUDY

Study objective: A preliminary study comparing the efficacy and safety of the flutter device (Flutter) to standard, manual chest physiothera py (CPT) in hospitalized cystic fibrosis (CF) patients undergoing an a cute pulmonary exacerbation. Design: Open label, comparative trial wit h alternate assignment. Setting: Community and childrens' hospital acu te-care wards. Participants: Twenty-two CF patients (ages 8 to 44 year s) undergoing a total of 33 hospitalizations for acute pulmonary exace rbation. Interventions: Complete pulmonary function tests (PFTs) were done at baseline (admission), weekly, and upon discharge from the hosp ital. Clinical score (CS) was determined at the time of hospital admis sion and at discharge. Participants were assigned to receive supervise d Flutter therapy or standard, manual CPT four times per day during th e hospitalization. Patients were monitored for complications, includin g hemoptysis, hypoxemia, and pneumothorax. Results: The groups (CPT an d Flutter) did not differ at baseline in demographics or Shwachman sco re, nor was length of hospitalization different. Significant improveme nts were noted from admission to discharge in CS and PFT results withi n each group, Mean percent change in CS and PFT results between CPT an d Flutter groups showed no significant difference from hospital admiss ion to discharge. Subsequent power analysis using the observed differe nce in percent change from admission to discharge for FEV1 indicated t hat to attain 80% power at alpha = 0.05, a sample of 219 subjects in e ach group would be necessary. Summary: Comparative trials of airway cl earance techniques with sufficient sample size are lacking. Although t he Flutter appears to be a useful device for independent, cost-effecti ve, and safe administration of CPT in this pilot study, a much larger clinical trial would be necessary to make definitive conclusions.