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Promotion of Regular Oesophageal Motility to Prevent Regurgitation and Enhance Nutrition Intake in Long-Stay ICU Patients. A Multicenter, Phase II, Sham-Controlled, Randomized Trial: The PROPEL Study.
Heyland, DK, Marquis, F, Lamontagne, F, Albert, M, Turgeon, AF, Khwaja, KA, Garland, A, Hall, R, Chapman, MG, Kutsiogannis, DJ, et al
Critical care medicine. 2020;(3):e219-e226
Abstract
OBJECTIVES To evaluate the effect of esophageal stimulation on nutritional adequacy in critically ill patients at risk for enteral feeding intolerance. DESIGN A multicenter randomized sham-controlled clinical trial. SETTING Twelve ICUs in Canada. PATIENTS We included mechanically ventilated ICU patients who were given moderate-to-high doses of opioids and expected to remain alive and ventilated for an additional 48 hours and who were receiving enteral nutrition or expected to start imminently. INTERVENTIONS Patients were randomly assigned 1:1 to esophageal stimulation via an esophageal stimulating catheter (E-Motion Tube; E-Motion Medical, Tel Aviv, Israel) or sham treatment. All patients were fed via these catheters using a standardized feeding protocol. MEASUREMENTS AND MAIN RESULTS The co-primary outcomes were proportion of caloric and protein prescription received enterally over the initial 7 days following randomization. Among 159 patients randomized, the modified intention-to-treat analysis included 155 patients: 73 patients in the active treatment group and 82 in the sham treatment group. Over the 7-day study period, the percent of prescribed caloric intake (± SE) received by the enteral route was 64% ± 2 in the active group and 65% ± 2 in sham patients for calories (difference, -1; 95% CI, -8 to 6; p = 0.74). For protein, it was 57% ± 3 in the active group and 60% ± 3 in the sham group (difference, -3; 95% CI, -10 to 3; p = 0.30). Compared to the sham group, there were more serious adverse events reported in the active treatment group (13 vs 6; p = 0.053). Clinically important arrhythmias were detected by Holter monitoring in 36 out of 70 (51%) in the active group versus 22 out of 76 (29%) in the sham group (p = 0.006). CONCLUSIONS Esophageal stimulation via a special feeding catheter did not improve nutritional adequacy and was associated with increase risk of harm in critically ill patients.
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Effects of combined exercise training and electromyostimulation treatments in chronic heart failure: A prospective multicentre study.
Iliou, MC, Vergès-Patois, B, Pavy, B, Charles-Nelson, A, Monpère, C, Richard, R, Verdier, JC, ,
European journal of preventive cardiology. 2017;(12):1274-1282
Abstract
Background Exercise training as part of a comprehensive cardiac rehabilitation is recommended for patients with cardiac heart failure. It is a valuable method for the improvement of exercise tolerance. Some studies reported a similar improvement with quadricipital electrical myostimulation, but the effect of combined exercise training and electrical myostimulation in cardiac heart failure has not been yet evaluated in a large prospective multicentre study. Purpose The aim of this study was to determine whether the addition of low frequency electrical myostimulation to exercise training may improve exercise capacity and/or muscular strength in cardiac heart failure patients. Methods Ninety-one patients were included (mean age: 58 ± 9 years; New York Heart Association II/III: 52/48%, left ventricular ejection fraction: 30 ± 7%) in a prospective French study. The patients were randomised into two groups: 41 patients in exercise training and 50 in exercise training + electrical myostimulation. All patients underwent 20 exercise training sessions. In addition, in the exercise training + electrical myostimulation group, patients underwent 20 low frequency (10 Hz) quadricipital electrical myostimulation sessions. Each patient underwent a cardiopulmonary exercise test, a six-minute walk test, a muscular function evaluation and a quality of life questionnaire, before and at the end of the study. Results A significant improvement of exercise capacity (Δ peak oxygen uptake+15% in exercise training group and +14% in exercise training + electrical myostimulation group) and of quality of life was observed in both groups without statistically significant differences between the two groups. Mean creatine kinase level increased in the exercise training group whereas it remained stable in the combined group. Conclusions This prospective multicentre study shows that electrical myostimulation on top of exercise training does not demonstrate any significant additional improvement in exercise capacity in cardiac heart failure patients.
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Impact of the feedback provided by a gastric electrical stimulation system on eating behavior and physical activity levels.
Busetto, L, Torres, AJ, Morales-Conde, S, Alarcón Del Agua, I, Moretto, C, Fierabracci, P, Rovera, G, Segato, G, Rubio, MA, Favretti, F
Obesity (Silver Spring, Md.). 2017;(3):514-521
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Abstract
OBJECTIVE The closed-loop gastric electrical stimulation (CLGES) abiliti® system provides tailored gastric electrical stimulation activated by food entry into the stomach and sensor-based data to medical professionals. The aim of this study was to analyze behavior changes using sensor-based food intake and activity data in participants treated with the CLGES system. METHODS Food intake and activity data (3D accelerometer) were downloaded at baseline and monthly/bimonthly for 12 months in a subset of patients with obesity (N = 45) participating in a multicenter trial with CLGES. Measured food intake parameters included the number of intakes during allowed and disallowed periods, nighttime intakes, and between-meal snacks (average/d). Activity parameters included time in different levels of physical activity (min/d), sleep/sedentary (h/d), and estimated energy expenditure (EE). RESULTS Weight loss at 12 months averaged 15.7 ± 7.7% of the baseline body weight. Stable reduction in the number of disallowed meals and between-meal snacks (P < 0.05), an increase in all levels of physical activity (P < 0.001), and an increase in activity-based EE (303 ± 53 kcal/d on average, P < 0.001) were seen. CONCLUSIONS Significant improvement in eating and activity was seen in participants. It is hypothesized that feedback of the sensor-based data induced behavioral changes and contributed to weight loss in patients treated with CLGES.
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Study protocol evaluating the use of bowel stimulation before loop ileostomy closure to reduce postoperative ileus: a multicenter randomized controlled trial.
Garfinkle, R, Trabulsi, N, Morin, N, Phang, T, Liberman, S, Feldman, L, Fried, G, Boutros, M
Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland. 2017;(11):1024-1029
Abstract
AIM: Postoperative ileus is the most commonly observed morbidity following ileostomy closure. Studies have demonstrated that the defunctionalized bowel of a loop ileostomy undergoes a series of functional and structural changes, such as atrophy of the intestinal villi and muscular layers, which may contribute to ileus. A single-centre study in Spain demonstrated that preoperative bowel stimulation via the distal limb of the loop ileostomy decreased postoperative ileus, length of stay and time to gastrointestinal function. METHOD A multicentre randomized controlled trial involving patients from Canadian institutions was designed to evaluate the effect of preoperative bowel stimulation before ileostomy closure on postoperative ileus. Stimulation will include canalizing the distal limb of the ileostomy loop with an 18Fr Foley catheter and infusing it with a solution of 500 ml of normal saline mixed with 30 g of a thickening agent (Nestle© Thicken-Up© ). This will be performed 10 times over the 3 weeks before ileostomy closure in an outpatient clinic setting by a trained Enterostomal Therapy nurse. Surgeons and the treating surgical team will be blinded to their patient's group allocation. Data regarding patient demographics, and operative and postoperative variables, will be collected prospectively. Primary outcome will be postoperative ileus, defined as an intolerance to oral food in the absence of clinical or radiological signs of obstruction, that either requires nasogastric tube insertion or is associated with two of the following on or after post-operative day 3: nausea/vomiting; abdominal distension; and the absence of flatus. Secondary outcomes will include length of stay, time to tolerating a regular diet, time to first passage of flatus or stool and overall morbidity. A cost analysis will be performed to compare the costs of conventional care with conventional care plus preoperative stimulation. DISCUSSION This manuscript discusses the potential benefits of preoperative bowel stimulation in improving postoperative outcomes and outlines our protocol for the first multicenter study to evaluate preoperative bowel stimulation before ileostomy closure. The results of this study could have considerable implications for the care of patients undergoing ileostomy closure.
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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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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.
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The EMPOWER study: randomized, prospective, double-blind, multicenter trial of vagal blockade to induce weight loss in morbid obesity.
Sarr, MG, Billington, CJ, Brancatisano, R, Brancatisano, A, Toouli, J, Kow, L, Nguyen, NT, Blackstone, R, Maher, JW, Shikora, S, et al
Obesity surgery. 2012;(11):1771-82
Abstract
BACKGROUND Intermittent, reversible intraabdominal vagal blockade (VBLOC® Therapy) demonstrated clinically important weight loss in feasibility trials. EMPOWER, a randomized, double-blind, prospective, controlled trial was conducted in USA and Australia. METHODS Five hundred three subjects were enrolled at 15 centers. After informed consent, 294 subjects were implanted with the vagal blocking system and randomized to the treated (n = 192) or control (n = 102) group. Main outcome measures were percent excess weight loss (percent EWL) at 12 months and serious adverse events. Subjects controlled duration of therapy using an external power source; therapy involved a programmed algorithm of electrical energy delivered to the subdiaphragmatic vagal nerves to inhibit afferent/efferent vagal transmission. Devices in both groups performed regular, low-energy safety checks. Data are mean ± SEM. RESULTS Study subjects consisted of 90 % females, body mass index of 41 ± 1 kg/m(2), and age of 46 ± 1 years. Device-related complications occurred in 3 % of subjects. There was no mortality. 12-month percent EWL was 17 ± 2 % for the treated and 16 ± 2 % for the control group. Weight loss was related linearly to hours of device use; treated and controls with ≥ 12 h/day use achieved 30 ± 4 and 22 ± 8 % EWL, respectively. CONCLUSIONS VBLOC® therapy to treat morbid obesity was safe, but weight loss was not greater in treated compared to controls; clinically important weight loss, however, was related to hours of device use. Post-study analysis suggested that the system electrical safety checks (low charge delivered via the system for electrical impedance, safety, and diagnostic checks) may have contributed to weight loss in the control group.
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Progress in implantable gastric stimulation: summary of results of the European multi-center study.
De Luca, M, Segato, G, Busetto, L, Favretti, F, Aigner, F, Weiss, H, de Gheldere, C, Gaggiotti, G, Himpens, J, Limao, J, et al
Obesity surgery. 2004;:S33-9
Abstract
BACKGROUND The Implantable Gastric Stimulator (IGS(R)), a pacemaker-like device, has been found to be safe and effective to induce and maintain weight loss. The LOSS (Laparoscopic Obesity Stimulation Survey) is a prospective non-randomized trial which enrolled 69 patients involving 11 investigator centers in 5 European Countries. In 19 patients, ghrelin was analyzed. METHODS Between January 2002 and December 2003, 69 patients (F/M 49/20), mean age 41 years (18-65) underwent IGS implantation. Mean BMI was 41 (35-57), mean weight 115.0 kg (65-160) and mean excess weight (EW) 52 kg (13-89). The IGS was actived 30 days after implantation. In a subset of 19 patients studied further, 0, 6, and 12 months appetite and satiety score were evaluated and 0 and 6 months ghrelin profile was analyzed. RESULTS The mean +/- standard error %EWL was: 8.6+/-1.8 at 1 month, 15.8+/-2.3 at 3 months, 17.8+/-2.6 at 6 months, 21.0+/-3.5 at 10 months, and 21.0+/-5.0 at 15 months. There were no intraoperative surgical or long-term complications. 7 intra-operative gastric penetrations occurred, observed by gastroscopy, without sequelae. 1 patient required a reoperation to remove a retained lead needle. In the subset of 19 patients, appetite was reduced and post-prandial and inter-prandial satiety was increased after IGS implantation. In the 19 patients, despite weight reduction, ghrelin did not increase. CONCLUSION IGS can be implanted laparoscopically with minimal perioperative complications. Appetite is reduced and satiety is increased after the implantation. Ghrelin levels could be one of the mechanisms explaining weight loss and weight maintenance in IGS patients. If weight loss is maintained, IGS could be considered a good option for selected patients.