Neuromuscular Electrical Stimulation in Mechanically Ventilated Patients

Neuromuscular Electrical Stimulation Clinical Trial

Official title: Effect of Neuromuscular Electrical Stimulation and Early Physical Activity on ICU Acquired Muscle Weakness in Mechanically Ventilated Patient: A Randomized Controlled Trial

Status Completed

Clinical Trial Summary

Intensive care unit-acquired muscle weakness (ICUAMW) is a common problem following an ICU admission and is associated with prolonged hospitalization, delayed weaning and increased mortality. Up to 25% of patients requiring mechanical ventilation (MV) for greater than 7 days develop ICUAW, and this figure may rise to 50-100% in the septic population. Long-term follow-up studies of survivors of critical illness have demonstrated significantly impaired health-related quality of life and physical functioning up to 5 years after ICU discharge, with weakness being the most commonly reported physical limitation. Early rehabilitation has been shown to be safe and feasible; however, commencement is often delayed due to a patient's inability to cooperate. An intervention that begins early in ICU admission without the need for patient volition may be beneficial in attenuating muscle wasting. Therefore, this study aims to evaluate the effect of neuromuscular electrical stimulation and early physical activity on ICU acquired muscle weakness in mechanically ventilated patient

Clinical Trial Description

A randomized controlled study will be carried out to achieve the aim of the current study. For three months, from July 15, 2022 to September 15, 2022, newly admitted patients will be screened. Patients in this trial will be recruited prospectively within 24 hours of admission to the general ICU. Computer-generated randomization will be used to assign patients to one of four groups: neuromuscular electrical stimulation (NMES), exercise (EX); combined therapy (NMES + EX); or conventional care (control group). A minimum total sample size of 120 samples will be included. According to sample size calculations treatment groups (NMES, EX, NMES + EX or conventional care) would be represented by a minimum of 30 patients. A total sample size a 120 will be selected for the study. All patients in the four groups will receive ICU standard care which includes sedation and weaning protocols.

Conventional care (Control Group):

Patients in this group will receive usual physiotherapy consisting of in-bed EXs and ICU standard care.

Exercise group (EX Group):

This group will receive passive/active exercise range of motion (ROM) exercises . ROM exercises will include major muscle groups (i.e. biceps, triceps, and lower limbs) and will be applied the second day of 1CU admission for seven days.

Neuromuscular Electrical Muscle Stimulation (NEMS Group):

Patients in NEMS group will receive neuromuscular electrical stimulation from the second day of ICU admission for seven days.

Neuromuscular electrical stimulation will be implemented simultaneously on the rectus femoris, vastus lateralis, and vastus medialis muscles of both lower limbs, with two stimulators, in two 30-min sessions per day starting from the second day after admission for seven days.

Combined therapy (NMES + EX):

Patients in this group will be subjected to NMES pulse EX. The application of NMES occurring simultaneously to the upper and lower limbs exercises.

The ICU acquired muscle weakness assessment tool will be developed by the researchers to assess and record occurrence of ICUAMW. ;

Related Conditions & MeSH terms

• Asthenia
• Muscle Weakness
• Neuromuscular Electrical Stimulation
• Paresis

• NCT number: NCT05465291
• Study type: Interventional
• Source: Damanhour University
• Status: Completed
• Phase: N/A
• Start date: October 18, 2022
• Completion date: February 18, 2023