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Neuromuscular electrical stimulation for intensive care unit-acquired weakness: protocol and methodological implications for a randomized, sham-controlled, phase II trial.

ABSTRACT: As the population ages and critical care advances, a growing number of survivors of critical illness will be at risk for intensive care unit (ICU)-acquired weakness. Bed rest, which is common in the ICU, causes adverse effects, including muscle weakness. Consequently, patients need ICU-based interventions focused on the muscular system. Although emerging evidence supports the benefits of early rehabilitation during mechanical ventilation, additional therapies may be beneficial. Neuromuscular electrical stimulation (NMES), which can provide some muscular activity even very early during critical illness, is a promising modality for patients in the ICU.The objectives of this article are to discuss the implications of bed rest for patients with critical illness, summarize recent studies of early rehabilitation and NMES in the ICU, and describe a protocol for a randomized, phase II pilot study of NMES in patients receiving mechanical ventilation.The study was a randomized, sham-controlled, concealed, phase II pilot study with caregivers and outcome assessors blinded to the treatment allocation.The study setting will be a medical ICU.The study participants will be patients who are receiving mechanical ventilation for 1 day or more, who are expected to stay in the ICU for an additional 2 days or more, and who meet no exclusion criteria.The intervention will be NMES (versus a sham [control] intervention) applied to the quadriceps, tibialis anterior, and gastrocnemius muscles for 60 minutes per day.Lower-extremity muscle strength at hospital discharge will be the primary outcome measure.Muscle strength is a surrogate measure, not a patient-centered outcome. The assessments will not include laboratory, genetic, or histological measures aimed at a mechanistic understanding of NMES. The optimal duration or dose of NMES is unclear.If NMES is beneficial, the results of the study will help advance research aimed at reducing the burden of muscular weakness and physical disability in survivors of critical illness.

SUBMITTER: Kho ME

PROVIDER: S-EPMC3513483 | biostudies-literature | 2012 Dec

REPOSITORIES: biostudies-literature

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Neuromuscular electrical stimulation for intensive care unit-acquired weakness: protocol and methodological implications for a randomized, sham-controlled, phase II trial.

Kho Michelle E ME Truong Alexander D AD Brower Roy G RG Palmer Jeffrey B JB Fan Eddy E Zanni Jennifer M JM Ciesla Nancy D ND Feldman Dorianne R DR Korupolu Radha R Needham Dale M DM

Physical therapy 20120315 12

<h4>Background</h4>As the population ages and critical care advances, a growing number of survivors of critical illness will be at risk for intensive care unit (ICU)-acquired weakness. Bed rest, which is common in the ICU, causes adverse effects, including muscle weakness. Consequently, patients need ICU-based interventions focused on the muscular system. Although emerging evidence supports the benefits of early rehabilitation during mechanical ventilation, additional therapies may be beneficial ...[more]

PMID: 22421734

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Project description:Intensive care unit-acquired weakness (ICU-AW) is the most common neuromuscular impairment in critically ill patients. We discuss critical aspects of ICU-AW that have not been completely defined or that are still under discussion. Critical illness polyneuropathy, myopathy, and muscle atrophy contribute in various proportions to ICU-AW. Diagnosis of ICU-AW is clinical and is based on Medical Research Council sum score and handgrip dynamometry for limb weakness and recognition of a patient's ventilator dependency or difficult weaning from artificial ventilation for diaphragmatic weakness (DW). ICU-AW can be caused by a critical illness polyneuropathy, a critical illness myopathy, or muscle disuse atrophy, alone or in combination. Its diagnosis requires both clinical assessment of muscle strength and complete electrophysiological evaluation of peripheral nerves and muscles. The peroneal nerve test (PENT) is a quick simplified electrophysiological test with high sensitivity and good specificity that can be used instead of complete electrophysiological evaluation as a screening test in non-cooperative patients. DW, assessed by bilateral phrenic nerve magnetic stimulation or diaphragm ultrasound, can be an isolated event without concurrent limb muscle involvement. Therefore, it remains uncertain whether DW and limb weakness are different manifestations of the same syndrome or are two distinct entities. Delirium is often associated with ICU-AW but a clear correlation between these two entities requires further studies. Artificial nutrition may have an impact on ICU-AW, but no study has assessed the impact of nutrition on ICU-AW as the primary outcome. Early mobilization improves activity limitation at hospital discharge if it is started early in the ICU, but beneficial long-term effects are not established. Determinants of ICU-AW can be many and can interact with each other. Therefore, future studies assessing early mobilization should consider a holistic patient approach with consideration of all components that may lead to muscle weakness.

Project description:BACKGROUND:The relationship between aminoglycoside use and intensive care unit (ICU)-acquired weakness remains controversial. In the present study, we performed a systematic review and meta-analysis to examine the relationship between aminoglycoside use and ICU-acquired weakness in critically ill patients. METHODS:The PubMed, Embase, Web of Science, Cochrane Central Register of Controlled Trials and Cumulative Index of Nursing and Allied Health Literature databases were searched from the earliest available date to July 10, 2019. Randomized controlled trials and prospective cohort studies examining the relationship between aminoglycosides and ICU-acquired weakness in adult ICU patients were included. Two authors independently screened titles/abstracts, reviewed full text and extracted data from the included studies. We performed the Meta-analysis using Stata version 15.0 and used the DerSimonian-Laird random effects model for data analyses. Heterogeneity was evaluated using the χ2 statistic and I2 statistic. Publication bias was evaluated with funnel plots qualitatively, the Begg's test and Egger's test quantitatively. RESULTS:Ten prospective cohort studies were included and analysed in this review. The overall effect sizes of the studies revealed a statistically significant relationship between aminoglycoside use and ICU-acquired weakness (OR, 2.06; 95%CI, 1.33-3.21; I2 = 56%). Subgroup and sensitivity analyses suggested a significant association between aminoglycoside use and studies limited to patients with clinical weakness (OR, 2.74; 95%CI, 1.83-4.10; I2 = 0%), and not to studies limited to patients with abnormal electrophysiology (OR, 1.78; 95%CI, 0.94-3.39; I2 = 59%), a large sample size (OR, 1.81; 95%CI, 0.97-3.39; I2 = 75%), or low risk of bias (OR, 1.59; 95%CI, 0.97-2.60; I2 = 56%); however, statistical heterogeneity was obvious. There were no significant publication biases found in the review. CONCLUSIONS:The review revealed a significant relationship between aminoglycoside use and ICU-acquired weakness.

Project description:BackgroundThe association between corticosteroid use and intensive care unit (ICU)-acquired weakness remains unclear. We evaluated the relationship between corticosteroid use and ICU-acquired weakness in critically ill adult patients.MethodsThe PubMed, Embase, Web of Science, Cochrane Central Register of Controlled Trials, and Cumulative Index of Nursing and Allied Health Literature databases were searched from database inception until October 10, 2017. Two authors independently screened the titles/abstracts and reviewed full-text articles. Randomized controlled trials and prospective cohort studies evaluating the association between corticosteroids and ICU-acquired weakness in adult ICU patients were selected. Data extraction from the included studies was accomplished by two independent reviewers. Meta-analysis was performed using Stata version 12.0. The results were analyzed using odds ratios (ORs) and 95% confidence intervals (CIs). Data were pooled using a random effects model, and heterogeneity was evaluated using the χ2 and I2 statistics. Publication bias was qualitatively analyzed with funnel plots, and quantitatively analyzed with Begg's test and Egger's test.ResultsOne randomized controlled trial and 17 prospective cohort studies were included in this review. After a meta-analysis, the effect sizes of the included studies indicated a statistically significant association between corticosteroid use and ICU-acquired weakness (OR 1.84; 95% CI 1.26-2.67; I2 = 67.2%). Subgroup analyses suggested a significant association between corticosteroid use and studies limited to patients with clinical weakness (OR 2.06; 95% CI 1.27-3.33; I2 = 60.6%), patients with mechanical ventilation (OR 2.00; 95% CI 1.23-3.27; I2 = 66.0%), and a large sample size (OR 1.61; 95% CI 1.02-2.53; I2 = 74.9%), and not studies limited to patients with abnormal electrophysiology (OR 1.65; 95% CI 0.92-2.95; I2 = 70.6%) or patients with sepsis (OR 1.96; 95% CI 0.61-6.30; I2 = 80.8%); however, statistical heterogeneity was obvious. No significant publication biases were found in the review. The overall quality of the evidence was high for the randomized controlled trial and very low for the included prospective cohort studies.ConclusionsThe review suggested a significant association between corticosteroid use and ICU-acquired weakness. Thus, exposure to corticosteroids should be limited, or the administration time should be shortened in clinical practice to reduce the risk of ICU-acquired weakness.

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Neuromuscular electrical stimulation for intensive care unit-acquired weakness: protocol and methodological implications for a randomized, sham-controlled, phase II trial.

Publications

Neuromuscular electrical stimulation for intensive care unit-acquired weakness: protocol and methodological implications for a randomized, sham-controlled, phase II trial.

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