SESSION TITLE: Cystic Fibrosis/ Bronchiectasis Posters
SESSION TYPE: Original Investigation Poster
PRESENTED ON: Wednesday, October 30, 2013 at 01:30 PM - 02:30 PM
PURPOSE: The device is a new, FDA-approved, high frequency focused-pulsation chest wall device for mobilization of pulmonary secretions. This study evaluated patient tolerance and the impact of the device on patient cardiopulmonary physiologic parameters.
METHODS: Control measurements were made prior to a 20 minute protocol with changes of the intensity and frequency delivery of the computer-controlled focused pulsations every 5 minutes. Heart rate (HR), blood pressure (BP), respiratory rate (RR), and peripheral oxygen saturation (SpO2) were measured while a 3-lead ECG strip was run continuously. Patient assessment of comfort and any symptoms were recorded before intervention, at 10 minutes, and at termination of intervention. Equivalence (within 15%) of the baseline, during-use, and termination measurements of parameters was assessed using the paired t-test for equivalence of means.
RESULTS: Eleven subjects (ages 26-86 and 6 males), are reported. One patient (9%) demonstrated >15% change in systolic and diastolic BP during evaluation. 7 of 11 (64%) patients showed a decrease of > 5% in HR (only 1 > 10%) and 4 (36%) showed an increase in HR > 5% (1 > 10%). One patient (9%) showed a decrease in SpO2 > 2% (3.0%) and 6 of 11 (55%) showed an increase in SpO2 of 2 - 8%. No cardiac arrythmias were demonstrated. Patient tolerance showed 10/11 patients (91%) found the device comfortable and easy to use. 8/11 (73%) had a cough stimulated. No patients complained of chest pain or dizziness.
CONCLUSIONS: The study demonstrates the safety of the device with minimal changes from patients’ pre-intervention cardiopulmonary parameters except for an increase in SpO2 in 55% of the patients. There were no cardiac arrythmias. Patient acceptance of the device was excellent and a cough was stimulated in 73% of patients. The new device provides a new method for mobilization of pulmonary secretions in patients.
CLINICAL IMPLICATIONS: The focused-pulsation chest wall device is a new method for mobilization of pulmonary secretions causing minimal, if any, change in cardiopulmonary parameters.
DISCLOSURE: Brice Taylor: Grant monies (from industry related sources): Brice Taylor is receiving grant monies to support an industry clinical trial on the Respin 11 device. Barrett Mitchell: Shareholder: Barrett Mitchell is the inventor of the Respin 11 device and the founder of Respinnovation, the sponsor of the IRB approved trial being reported. William Marshall: Consultant fee, speaker bureau, advisory committee, etc.: William Marshall is a consultant for Respinnovation and assisted in the design of the clinical trial reported.
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