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

NCT ID: NCT02391103

Last Updated: 2015-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2015-03-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

NMES group

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.

Group Type: EXPERIMENTAL

Compex 3 Professional (CefarCompex Medical AB) stimulator

Intervention Type: DEVICE

NMES

Control group

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

Group Type: SHAM_COMPARATOR

sham-stimulation

Intervention Type: DEVICE

no electricity applied

Interventions

Compex 3 Professional (CefarCompex Medical AB) stimulator

NMES

Intervention Type: DEVICE

sham-stimulation

no electricity applied

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Arabella Fischer, MD

resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Hiesmayr, MD, Prof.

Role: STUDY_DIRECTOR

Medical University of Vienna

Arabella Fischer, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

References

Gerovasili V, Stefanidis K, Vitzilaios K, Karatzanos E, Politis P, Koroneos A, Chatzimichail A, Routsi C, Roussos C, Nanas S. Electrical muscle stimulation preserves the muscle mass of critically ill patients: a randomized study. Crit Care. 2009;13(5):R161. doi: 10.1186/cc8123. Epub 2009 Oct 8.

Reference Type: BACKGROUND

PMID: 19814793 (View on PubMed)

Hirose T, Shiozaki T, Shimizu K, Mouri T, Noguchi K, Ohnishi M, Shimazu T. The effect of electrical muscle stimulation on the prevention of disuse muscle atrophy in patients with consciousness disturbance in the intensive care unit. J Crit Care. 2013 Aug;28(4):536.e1-7. doi: 10.1016/j.jcrc.2013.02.010. Epub 2013 Apr 3.

Reference Type: BACKGROUND

PMID: 23561945 (View on PubMed)

Rodriguez PO, Setten M, Maskin LP, Bonelli I, Vidomlansky SR, Attie S, Frosiani SL, Kozima S, Valentini R. Muscle weakness in septic patients requiring mechanical ventilation: protective effect of transcutaneous neuromuscular electrical stimulation. J Crit Care. 2012 Jun;27(3):319.e1-8. doi: 10.1016/j.jcrc.2011.04.010. Epub 2011 Jun 28.

Reference Type: BACKGROUND

PMID: 21715139 (View on PubMed)

Kho ME, Truong AD, Zanni JM, Ciesla ND, Brower RG, Palmer JB, Needham DM. Neuromuscular electrical stimulation in mechanically ventilated patients: a randomized, sham-controlled pilot trial with blinded outcome assessment. J Crit Care. 2015 Feb;30(1):32-9. doi: 10.1016/j.jcrc.2014.09.014. Epub 2014 Sep 22.

Reference Type: BACKGROUND

PMID: 25307979 (View on PubMed)

Abdellaoui A, Prefaut C, Gouzi F, Couillard A, Coisy-Quivy M, Hugon G, Molinari N, Lafontaine T, Jonquet O, Laoudj-Chenivesse D, Hayot M. Skeletal muscle effects of electrostimulation after COPD exacerbation: a pilot study. Eur Respir J. 2011 Oct;38(4):781-8. doi: 10.1183/09031936.00167110. Epub 2011 Feb 24.

Reference Type: BACKGROUND

PMID: 21349913 (View on PubMed)

Routsi C, Gerovasili V, Vasileiadis I, Karatzanos E, Pitsolis T, Tripodaki E, Markaki V, Zervakis D, Nanas S. Electrical muscle stimulation prevents critical illness polyneuromyopathy: a randomized parallel intervention trial. Crit Care. 2010;14(2):R74. doi: 10.1186/cc8987. Epub 2010 Apr 28.

Reference Type: BACKGROUND

PMID: 20426834 (View on PubMed)

Zanotti E, Felicetti G, Maini M, Fracchia C. Peripheral muscle strength training in bed-bound patients with COPD receiving mechanical ventilation: effect of electrical stimulation. Chest. 2003 Jul;124(1):292-6. doi: 10.1378/chest.124.1.292.

Reference Type: BACKGROUND

PMID: 12853536 (View on PubMed)

Puthucheary ZA, Phadke R, Rawal J, McPhail MJ, Sidhu PS, Rowlerson A, Moxham J, Harridge S, Hart N, Montgomery HE. Qualitative Ultrasound in Acute Critical Illness Muscle Wasting. Crit Care Med. 2015 Aug;43(8):1603-11. doi: 10.1097/CCM.0000000000001016.

Reference Type: BACKGROUND

PMID: 25882765 (View on PubMed)

Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. doi: 10.1001/jama.2013.278481.

Reference Type: BACKGROUND

PMID: 24108501 (View on PubMed)

Fischer A, Spiegl M, Altmann K, Winkler A, Salamon A, Themessl-Huber M, Mouhieddine M, Strasser EM, Schiferer A, Paternostro-Sluga T, Hiesmayr M. Muscle mass, strength and functional outcomes in critically ill patients after cardiothoracic surgery: does neuromuscular electrical stimulation help? The Catastim 2 randomized controlled trial. Crit Care. 2016 Jan 29;20:30. doi: 10.1186/s13054-016-1199-3.

Reference Type: DERIVED

PMID: 26825278 (View on PubMed)

Other Identifiers

1072/2010

Identifier Type: -

Identifier Source: org_study_id