Effects of Neuromuscular Electrical Stimulation on Muscle Mass and Strength in Critically Ill Patients After Cardiothoracic Surgery

Study Overview
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Brief Summary
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The purposes of this study are 1) to determine whether neuromuscular electrical stimulation (NMES) is effective in preventing loss of muscle mass and strength and 2) to observe the time variation of MLT and strength from preoperative day to hospital discharge.

Detailed Description
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In the amendment of June 2011, a twofold study setting was defined in order to recruit patients not only before, but also after cardiothoracic surgery. In sample A, patients were recruited before surgery. In sample B, patients were recruited after surgery. On postoperative day 1, randomization was performed for sample A and B separately. To ensure balance of the NMES and control groups with respect to disease severity, randomization was stratified by the SAPS II score on the first postoperative day. In the intervention group, the anterior muscles of both thighs were electrically stimulated from the first postoperative day until ICU discharge for a maximum of 14 days. In the control group, the electrodes were applied, but no electricity was delivered.The primary outcomes muscle layer thickness (MLT) and muscle strength were assessed from the first postoperative day to ICU discharge and at hospital discharge. All patients in sample A had an additional assessment of MLT and strength before surgery. All data are analyzed according to the intention-to-treat principle with no imputation for any missing data. Linear mixed models are used to account for the repeated measurements per patient and to determine any fixed effects on MLT and MRC score.

Official Title
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Effects of Neuromuscular Electrical Stimulation on Muscle Mass and Strength in Critically Ill Patients After Cardiothoracic Surgery. An Ultrasound-Based Randomized Controlled Trial

Conditions
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Neuromuscular Electrical Stimulation, Intensive Care Unit Acquired Weakness, Muscle Wasting, Muscle Loss

Intervention / Treatment
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* Device: Compex 3 Professional (CefarCompex Medical AB) stimulator
* Device: sham-stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients before/after cardiothoracic surgery ICU stay > 48 hours Exclusion Criteria: body mass index > 40 kg/m2 severe leg swelling implanted ventricular assist device (RVAD, LVAD, BiVAD) implanted intra-aortic balloon pump (IABP) neuromuscular diseases skin lesions in stimulation area leg excluded if implant (hip or knee replacement) in stimulation area

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NMES group<br>Anterior muscles of both thighs were electrically stimulated twice a day (2×30 minutes of NMES with a break of at least 30 minutes between both sessions) 7 days a week during the entire ICU stay but no longer than 14 days, starting on postoperative day 1. Highest tolerable intensity was applied. | Device: Compex 3 Professional (CefarCompex Medical AB) stimulator<br>* NMES<br>|
| Sham Comparator: Control group<br>In the control group, the electrodes were applied, connected to the stimulator, but no electricity was delivered. | Device: sham-stimulation<br>* no electricity applied<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle layer thickness (MLT) | Muscle layer thickness of the anterior muscles of the thigh using two-dimensional B-mode ultrasound | on preoperative day, from postoperative day 1 onwards every other ICU day for the duration of the ICU stay (expected average of ICU stay: 7 days) and at day of hospital discharge (expected average of hospital stay: 20 days) | 
| Muscle strength | Muscle strength using Medical Research Council (MRC) score and hand dynamometry | on preoperative day, from postoperative day 1 onwards every day for the duration of the ICU stay (expected average of ICU stay: 7 days), at day of hospital discharge (expected average of hospital stay: 20 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| JAGS score | JAGS score | on preoperative day, on day of ICU discharge (expected average of ICU stay: 7 days), on day of hospital discharge (expected average of hospital stay: 20 days) | 
| Timed Up and Go test | Timed Get Up and Go test | on preoperative day, on day of hospital discharge (expected average of hospital stay: 20 days) | 
| FIM score | Functional Independance Measure (FIM) score | on preoperative day, on day of hospital discharge (expected average of hospital stay: 20 days) | 
| SF-12 score | 12-item Short Form Health Survey (SF-12) | on preoperative day, on day of hospital discharge (expected average of hospital stay: 20 days) |