Neuromuscular Electrical Stimulation for Intensive Care Unit-acquired Weakness Assessment

Polyneuropathy, Critical Illness Clinical Trial

— ENS  

Official title:

Neuromuscular Electrical Stimulation for Intensive Care Unit-acquired Weakness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02706587
• Other study ID #: REA 01-2014
• Status: Recruiting
• Phase: Phase 3
• First received: February 10, 2016
• Last updated: September 12, 2016
• Start date: March 2016
• Est. completion date: June 2018

Study information

• Verified date: September 2016
• Source: Institut Mutualiste Montsouris
• Contact: Christian Lamer, MD
• Phone: +33156616188
• Email: christian.lamer[@]imm.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether early neuromuscular electrical stimulation is effective in the prevention of neuromuscular weakness in critical ill patients.

Description:

Randomized, controlled study of early electrical neurostimulation (vs sham) in critically ill patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: June 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patient

• Aged of 18 or more

• With an intended ICU stay of at least 72 hours

• Mechanically ventilated

Exclusion Criteria:

• Age less than 18 years

• Pregnant women

• Preexisting neuromuscular disease

• Patient bearing a pace maker or an implantable defibrillator.

• Poly traumatism and/or leg fracture.

• End stage disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Critical Illness
• Polyneuropathies
• Polyneuropathy, Critical Illness

Intervention

Device:
• Neuromuscular electrical stimulation
NEMS is delivered bilaterally to the quadriceps femoris muscle using a portable battery-powered stimulator (Rehab 400, Cefar Compex, France). The electrodes are placed on the motor points of vastus medialis and vastus lateralis muscles. Electrical stimuli of 45Hz (pulse width: 380 µseconds; 6 seconds on with 1.5 second rise time; and 0.75 seconds fall time.; 5 seconds off). The current is adjusted to ensure maximum tolerable muscle contraction The protocol is applied twice daily for 25 minutes, five days a week.
• Sham control
No electrostimulation

Locations

Country	Name	City	State
France	Insitut Mutualiste Montsouris	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Institut Mutualiste Montsouris	Assistance Publique - Hôpitaux de Paris, Fondation Paul Bennetot

Country where clinical trial is conducted

France, 

References & Publications (4)

Kho ME, Truong AD, Brower RG, Palmer JB, Fan E, Zanni JM, Ciesla ND, Feldman DR, Korupolu R, Needham DM. Neuromuscular electrical stimulation for intensive care unit-acquired weakness: protocol and methodological implications for a randomized, sham-controlled, phase II trial. Phys Ther. 2012 Dec;92(12):1564-79. doi: 10.2522/ptj.20110437. Epub 2012 Mar 15. — View Citation

Kress JP, Hall JB. ICU-acquired weakness and recovery from critical illness. N Engl J Med. 2014 Apr 24;370(17):1626-35. doi: 10.1056/NEJMra1209390. Review. — View Citation

Needham DM, Truong AD, Fan E. Technology to enhance physical rehabilitation of critically ill patients. Crit Care Med. 2009 Oct;37(10 Suppl):S436-41. doi: 10.1097/CCM.0b013e3181b6fa29. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medical resuscitation council (MRC) score		up to 25 months. From date of randomization to the date of ICU discharge	No
Secondary	Total duration of mechanical ventilation (days)		up to 25 months. From date of randomization to the date of ICU discharge	No
Secondary	Length of ICU stay and hospital stay.		up to 25 months. From date of randomization to the date of ICU discharge or hospital discharge	No
Secondary	Type of hospital discharge	(alive/deceased/rehabilitation/home...)	up to 25 months. From date of randomization to the date of hospital discharge	No