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Safety and feasibility of a neuromuscular electrical stimulation chronaxie-based protocol in critical ill patients: A prospective observational study.
Silva, PE, Babault, N, Mazullo, JB, de Oliveira, TP, Lemos, BL, Carvalho, VO, Durigan, JLQ
Journal of critical care. 2017;:141-148
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Abstract
PURPOSE The aim of this study was to evaluate the safety and feasibility of a neuromuscular electrical stimulation (NMES) protocol based on neuromuscular excitability and applied in numerous muscle groups of critical ill patients. MATERIALS AND METHODS We performed a prospective observational study using an NMES applied daily and bilaterally into 5 muscle groups in lower limbs for 3 consecutive days. The characteristics of NMES were 90 contractions per muscle, pulse width equal to chronaxie, and a pulse frequency of 100 Hz. We assessed safety with central venous oxygen saturation, serum lactate, and creatine phosphokinase measurements. To evaluate feasibility, we recorded the time spent for the entire NMES protocol and the number of NMES sessions completed. RESULTS Eleven male patients finished the study. There were no significant changes observed in creatine phosphokinase from baseline up to 96 hours: 470(±270) IU/L and 455(±240) IU/L (P>.99). Central venous oxygen saturation and serum lactate had the same pattern with no significant variations (P=.23 and P=.8, respectively). The time spent during the whole procedure and the number of complete NMES sessions performed were 107±24 minutes and 84 sessions (85%), respectively. CONCLUSIONS We demonstrated that NMES chronaxie-based protocol is safe and feasible.
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abiliti Closed-Loop Gastric Electrical Stimulation System for Treatment of Obesity: Clinical Results with a 27-Month Follow-Up.
Horbach, T, Thalheimer, A, Seyfried, F, Eschenbacher, F, Schuhmann, P, Meyer, G
Obesity surgery. 2015;(10):1779-87
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Abstract
BACKGROUND The aim of the study was to evaluate the safety and effectiveness of a novel closed-loop gastric electric stimulation device (abiliti system) featuring a transgastric sensor to detect food intake and an accelerometer to record physical activity to induce and maintain lifestyle changes to treat obesity. METHODS In a prospective, multi-center study, 34 obese subjects (BMI of 42.1 ± 5.3 kg/m(2)) who passed an eligibility evaluation were implanted with the abiliti system. Safety evaluation included an endoscopic exam to assess the intragastric electrode healing. Efficacy evaluation at 1 year of therapy included weight loss, improvements in eating, and exercise behavior and quality of life. RESULTS The transgastric implant controlled by endoscopy was stable for all participants. At 12 months (12 M) the mean excess weight loss (EWL) was 28.7% (95%CI, 34.5 to 22.5%), and mean reduction in BMI was 4.8 ± 3.2 kg/m(2). At 27 months (27 M), the EWL was 27.5% (95% CI, 21.3% to 33.7%). Eating behavior, evaluated by the "Three Factor Eating Questionnaire", showed a significant increase in the cognition factor and decrease in the disinhibition and hunger factors at 12 M in comparison to baseline (p < 0.001). Participants significantly increased their weekly physical activity (p < 0.001). Quality of life was improved in 55.2% of the patients. CONCLUSIONS Gastric electrical stimulation with abiliti system in obese participants is well tolerated and leads to significant 12 M weight loss, which was stable to 27 M. We suggest that weight loss is achieved due to the assessed alteration of eating behavior in particular the reduction in disinhibition and hunger, and the measured increase in physical activity.