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Hill-Rom HFCWO and The Vest® Airway Clearance System Studies: Long-Term Home Care Airway Clearance Patients Article Citation Warwick WJ, Hansen L. The long-term effect of high-frequency chest compression therapy on pulmonary complications of cystic fibrosis. Pediatr Pulmonol 1991; 11: 265-271. Type of Study Retrospective Self-controlled Number (n) & Type of Subjects 16 cystic fibrosis patients Protocol • Daily HFCC for 30-minute sessions of 5-minute periods at 6 different frequencies • Therapy time ranged from 30-240 minutes in 1-4 treatments/day for a mean of 21.6 months (range = 7-26 months) • Results compared with pre-HFCC CPT administered 1-4x/day for a mean of 23.2 months (range = 14-27 months) • Coughing and huffing techniques employed Anbar RD, Powell KN, Iannuzzi DM. Short-term effect of ThAIRapy Vest on pulmonary function of cystic fibrosis patients. Am J Respir Crit Care Med 1998; 157 (suppl 3): A 130 Retrospective Self-controlled 54 cystic fibrosis patients Results • 94% of patients' regression line slopes became more positive during self-administered HFCC therapy as compared to slopes calculated from pulmonary function scores obtained before HFCC was substituted for CPT • The Vest® System associated with sustained or improved PFTs in 15 of 16 subjects • No treatment-associated adverse events observed • Daily HFCWO administered for an average of 19 ± 13 minutes for at least 6 months • Improvement in FEV1 of patients who had performed CPT prior to switching to The Vest® System was 7% • Results compared with best pre-HFCWO PFTs from previous 0-6 months • Improvement in patients who did not use CPT prior to beginning therapy with The Vest® System was 11% • HFCWO therapy with The Vest® System improved lung function of all subjects in the short term regardless of prior use of CPT • No treatment-associated adverse events observed Giarraffa P, Berger K, Chaikin A, Axelrod F, Davey C, Becker B. Assessing Efficacy of High Frequency Chest Wall Oscillation in Patients with Familial Dysautonomia. Chest 2005; 128:3377-3381. Retrospectiveprospective self-controlled 15 familial dysautonomia patients • Twice daily HFCWO for 20 to 30 minute sessions • Pulmonary function tests, chest radiograph and blood tests at study entrance • Retrospective chart review 12 months prior to entry provided baseline data for respiratory illnesses, medications, doctor visits, hospitalizations, and absenteeism • Daily log recording of prospective data for same parameters and HFCWO treatment adherence • HFCWO was associated with significant improvements in the following measured outcomes: o o o o o o Pneumonias (p = 0.0156) Hospitalizations (p = 0.0161) Antibiotic courses (p = 0.0005) Antibiotic days (p = 0.0002) Doctor visits (p = 0.0005) Absenteeism (p = 0.0002) • Evaluations at 1, 3, 6, 9, and 12 months for pulse oximetry, spirometry and log review • Exit blood tests and chest radiographs Landon C, Goldie W, Evans JR. Airway Clearance Therapy utilizing High Frequency Chest Wall Oscillation for medically fragile children. Unpublished clinical study data, 2001. Retrospective prospective 15 medically complex children (MCC) 15 MCC who had been treated with daily CPT received The Vest® System Therapy for at least 12 months After at least 12 months of The Vest® System, 15 medically complex children showed an aggregate… • The Vest® System Therapy 2x daily for 15-20 minutes at 15 Hz and pressure settings of 5-6 • Three-fold reduction in total hospital days (21 days with The Vest® System vs. 66 days pre-HFCWO) • Prospective data for total days hospitalized and total ICU days compared with retrospective • The elimination of ICU days (0 days with The Vest® System vs. 34 days pre-HFCWO) • 90% tolerance • No treatment-associated adverse events observed Hill-Rom HFCWO and The Vest® Airway Clearance System Studies: Long-Term Home Care Airway Clearance Patients Article Citation Plioplys AV, Lewis S, Kasnicka I. Pulmonary vest therapy in quadriplegic cerebral palsy. J Am Med Dir Assoc 2002; 3: 318-321. Type of Study Retrospectiveprospective self-controlled Number (n) & Type of Subjects 7 quadriplegic cerebral palsy patients with lung disease Protocol • 12 month prospective daily therapy with The Vest® System • Twelve month retrospective clinical data collected from nursing records maintained daily according to residential facility protocol provided baseline data for CPT therapy schedules, pneumonias, hospitalizations, seizures, and effective suctioning • Twelve month prospective data collected for same parameters during therapy with The Vest® System Results • Clinical outcomes after 12 months of The Vest® System Therapy showed: Pneumonias (n) Hospitalizations (n) Seizures (n) Effective suctioning (n) Before VT During VT P value* 36 18 P = 0.026 9 3 P = 0.160 267 43 P = 0.125 4,825 10,455 P = 0.008 • No reports of significant adverse events Subjects randomized and then crossed over to receive either • No episodes of bronchospasm occurred in 13 asthmatic subjects receiving HFCWO Wen AS, Woo MS, Keens TG. Safety of chest physiotherapy in asthma. Am J Respir Crit Care Med 1996; 153 (Suppl): A 77. Randomized, Crossover, Controlled 13 asthmatic patients Ndukwu, IM, Shapiro S, Nam AJ, Schumm PL. Comparison of High Frequency Chest Wall Oscillation (HFCWO) and manual chest physiotherapy (mCPT) in long-term acute care hospital (LTAC) ventilatordependent patients. Chest 1999; 116 (4) Suppl 2: 311S. Randomized, Controlled 54 ventilatordependent individuals hospitalized in a long-term acute care facility Subjects ventilated for a median of 84 days were assigned to receive either • After 21 days, patients randomized to HFCWO had cleared greater volumes of sputum (p = 0.114) • manual chest physiotherapy (mCPT) • High Frequency Chest Wall Oscillation (HFCWO) via The Vest® Airway Clearance System • mCPT: 15 minutes, 4 times a day for 40 days • HFCWO: 15 minutes, 4 times a day for 40 days • After 40 days, HFCWO patients experienced a more than two-fold greater rate of successful weaning from the ventilator: 10/26 vs. 4/28 (p = 0.063) J David Rhodes, Nancy V Lemons, Della J Coupland, Sean C Orr, Rodney D Soto, Camilo R Gomez, Univ of AlabamaBirmingham, Birmingham, AL. Simultaneous Application of Vibrating Vest and Cough Assist Device Improve Respiratory Function in Stroke Patient. Presented at the 28th International Stroke Conference, Phoenix, AZ. 2003. [Abstract ID: 100980; PubNumber: P322] Prospective 10 stroke patients 10 acute stroke patients were treated with either a combination of The Vest® Airway Clearance System Therapy and a mechanical cough-assisting device or CPT for at least 3 days. • The Vest® Airway Clearance System/cough assist patients showed significant improvement in: • All patients received nebulized bronchodilators every 4 hours • Pulmonary function measures before and after each treatment using bedside spirometry • Analysis of variance (ANOVA) used to compare effects of each treatment • Minute ventilations (Ve) [p = 0.02] • Nebulized bronchodilator (NB) treatment • NB plus HFCWO on different days • PFTs measured before and after a nebulized bronchodilator treatment • PFTs measured before and after 30 minutes of HFCC administered with a nebulized bronchodilator treatment • PFTs include FEV1, RV/TLC, Raw, SGaw, PETC02, SP02 Hill-Rom reserves the right to make changes without notice in design, specifications and models. The only warranty Hill-Rom makes is the express written warranty extended on the sale or rental of its products. © 2007 Hill-Rom Services, Inc. – ALL RIGHTS RESERVED. 6/1/07 France . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .+33 (0)2 97 50 92 12 United Kingdom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .+44 (0)1530 411000 Deutschland . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .+49 (0)211/16450-0 Nederland . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .+31 (0)347 32 35 32 Italia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .+39 02-950541 Suisse/Schweiz . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .+41 (0)21/706 21 30 (deutschsprachig) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .021/706 21 38 Österreich . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .+43 (0)2243 / 28550 Ireland . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .+353 (0)1 413 6005 Iberia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .+34 (0)93 6856000 Nordic Countries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .+46 (0)8 564 353 60 Export . . . . . . . . . . . . . . . . . . . . . . . . .contact your local Hill-Rom distributor . . . . . . . . . . . . . . . . . . . . . . . . . . .or contact your Area manager via website . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .or call +1 812 934 8173 • Forced vital capacity (FVC) [p = 0.0001] • The Vest® Airway Clearance System/cough assist patients showed a positive trend in SpO2 [p = 0.08]