OBJECTIVE: To determine the long-term effects of the cough stimulation system. DESIGN: Nonrandomized clinical trial of subjects using the study device well beyond the period of close follow-up. SETTING: Use of the study device in the home setting. PARTICIPANTS: Subjects (N = 10) implanted with the device for a minimum of 2 years (mean 4.6 ± 0.6 years). INTERVENTIONS: Application of daily stimulation. OUTCOME MEASURES: Airway pressure generation and other clinical assessments including ease in raising secretions, life quality, caregiver support, and incidence of respiratory tract infections were measured at 1 year and mean 4.6 years after implantation. RESULTS: Each subject continued to use the device on a regular basis. During SCS, mean maximum airway pressures were 103.1 ± 20.4 and 107.7 ± 23.0 cm H₂O at the 1-year and mean 4.6-year follow-up points, respectively (P < 0.05 compared with pre-implant and not significantly different (NS) compared with 1-year follow-up). Benchmarks related to ease in raising secretions and improvements in life quality related to respiratory care were maintained at the mean 4.6 year follow-up. The need for trained caregivers to provide other means of secretion management remained significantly below the pre-implant values (P < 0.05). The incidence of acute respiratory tract infections remained low at 0.2 ± 0.1 events/year, which is significantly below the pre-implant value of 1.4 ± 0.3 events/year (P < 0.05). CONCLUSION: Subjects continued to use the system on a long-term basis beyond the period of close follow-up and to continued derive significant clinical benefits.
OBJECTIVE: To determine the long-term effects of the cough stimulation system. DESIGN: Nonrandomized clinical trial of subjects using the study device well beyond the period of close follow-up. SETTING: Use of the study device in the home setting. PARTICIPANTS: Subjects (N = 10) implanted with the device for a minimum of 2 years (mean 4.6 ± 0.6 years). INTERVENTIONS: Application of daily stimulation. OUTCOME MEASURES: Airway pressure generation and other clinical assessments including ease in raising secretions, life quality, caregiver support, and incidence of respiratory tract infections were measured at 1 year and mean 4.6 years after implantation. RESULTS: Each subject continued to use the device on a regular basis. During SCS, mean maximum airway pressures were 103.1 ± 20.4 and 107.7 ± 23.0 cm H₂O at the 1-year and mean 4.6-year follow-up points, respectively (P < 0.05 compared with pre-implant and not significantly different (NS) compared with 1-year follow-up). Benchmarks related to ease in raising secretions and improvements in life quality related to respiratory care were maintained at the mean 4.6 year follow-up. The need for trained caregivers to provide other means of secretion management remained significantly below the pre-implant values (P < 0.05). The incidence of acute respiratory tract infections remained low at 0.2 ± 0.1 events/year, which is significantly below the pre-implant value of 1.4 ± 0.3 events/year (P < 0.05). CONCLUSION: Subjects continued to use the system on a long-term basis beyond the period of close follow-up and to continued derive significant clinical benefits.
Authors: Sanjeev Agarwal; Ronald J Triolo; Rudi Kobetic; Michael Miller; Carol Bieri; Sahana Kukke; Lori Rohde; John A Davis Journal: J Rehabil Res Dev Date: 2003 May-Jun
Authors: K J Burchiel; V C Anderson; F D Brown; R G Fessler; W A Friedman; S Pelofsky; R L Weiner; J Oakley; D Shatin Journal: Spine (Phila Pa 1976) Date: 1996-12-01 Impact factor: 3.468
Authors: Anthony F DiMarco; Krzysztof E Kowalski; Robert T Geertman; Dana R Hromyak; Fredrick S Frost; Graham H Creasey; Gregory A Nemunaitis Journal: Arch Phys Med Rehabil Date: 2009-05 Impact factor: 3.966
Authors: Rob McCarney; James Warner; Steve Iliffe; Robbert van Haselen; Mark Griffin; Peter Fisher Journal: BMC Med Res Methodol Date: 2007-07-03 Impact factor: 4.615
Authors: James S Walter; Joseph Posluszny; Raymond Dieter; Robert S Dieter; Scott Sayers; Kiratipath Iamsakul; Christine Staunton; Donald Thomas; Mark Rabbat; Sanjay Singh Journal: J Spinal Cord Med Date: 2017-06-14 Impact factor: 1.985
Authors: Elisa J Gonzalez-Rothi; Kristi A Streeter; Marie H Hanna; Anna C Stamas; Paul J Reier; David M Baekey; David D Fuller Journal: J Neurophysiol Date: 2017-06-14 Impact factor: 2.714
Authors: Anthony F DiMarco; Robert T Geertman; Kutaiba Tabbaa; Rebecca R Polito; Krzysztof E Kowalski Journal: J Spinal Cord Med Date: 2017-10-11 Impact factor: 1.985
Authors: L M Mercier; E J Gonzalez-Rothi; K A Streeter; S S Posgai; A S Poirier; D D Fuller; P J Reier; D M Baekey Journal: J Neurophysiol Date: 2016-11-23 Impact factor: 2.714
Authors: Anthony F DiMarco; Robert T Geertman; Kutaiba Tabbaa; Gregory A Nemunaitis; Krzysztof E Kowalski Journal: J Spinal Cord Med Date: 2019-12-06 Impact factor: 1.985