Effects of Neuromuscular Electrical Stimulation on Muscle Mass and Strength in Critically Ill Patients After Cardiothoracic Surgery (Catastim 2)

Medical University of Vienna

Status: Completed

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02391103

1072/2010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups

NMES group

Experimental group

Description:

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.

Treatment:

Device: Compex 3 Professional (CefarCompex Medical AB) stimulator

Control group

Sham Comparator group

Description:

In the control group, the electrodes were applied, connected to the stimulator, but no electricity was delivered.

Treatment:

Device: sham-stimulation