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

Not Applicable

Completed

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

Interventions: Device: Compex 3 Professional (CefarCompex Medical AB) stimulator
Device: sham-stimulation

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
NMES group	Compex 3 Professional (CefarCompex Medical AB) stimulator	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.
Control group	sham-stimulation	In the control group, the electrodes were applied, connected to the stimulator, but no electricity was delivered.

Primary Outcome Measures

Name	Time	Method
Muscle layer thickness (MLT)	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 layer thickness of the anterior muscles of the thigh using two-dimensional B-mode ultrasound
Muscle strength	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)	Muscle strength using Medical Research Council (MRC) score and hand dynamometry

Secondary Outcome Measures

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