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NCT Number: NCT05465291

Neuromuscular Electrical Stimulation in Mechanically Ventilated Patients

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

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Key information

Conditions

Neuromuscular Electrical Stimulation ICU Acquired Muscle Weakness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of nursing

Damanhur, Beheira, 045/3300376, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged ≥18 years,
  • mechanically ventilated for ≥48 h
  • remain in the intensive care ≥4 days.

Exclusion criteria

  • Pre-existing neuromuscular disease
  • brain death
  • peripheral vascular diseases (arterial lower limb disease and deep venous thrombosis)
  • hemiplegia/quadriplegia
  • lower limb amputation
  • spinal injuries
  • receiving muscle relaxant; cognitive impairment; body mass index (BMI) > 35 kg/m2; bone fractures
  • skin lesions
  • presence of cardiac pacemaker
  • end-stage cancer

Treatment and study plan

Exercise Group

Procedure

This group will receive passive/active range of motion (ROM) exercises. ROM exercises will include major muscle groups (i.e. biceps, triceps, and lower limbs) and will be applied from second day till seventh day of admission .

Other names: EX Group

Neuromuscular Electrical Muscle Stimulation group

Procedure
  • Patients in NEMS group will receive neuromuscular electrical stimulation from second day till seventh day of admission.
  • 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 till seventh day of admission .

Other names: NEMS group

Neuromuscular Electrical Muscle Stimulation and Exercise group

Procedure

Patients in this group will be subjected to Neuromuscular Electrical Muscle Stimulation and Exercise.

Other names: NMES + EX group

Primary outcomes

  1. Assessing a change in limb muscle strength

    Time frame: on day 2 of ICU admission, on day 3, and on day 5.

    Limb muscle strength using Medical Research Council score (MRCS). Three muscle groups in all four limbs will be assessed with the MRC scale with values ranging from 0 (quadriplegia….severe muscle weakness) to 60 (normal muscle strength).

Secondary outcomes

  1. Time to weaning off the ventilator

    Time frame: After day 2 of ICU admission and on day 5.

    Time to weaning off the ventilator

  2. Duration of MV

    Time frame: After day 2 of ICU admission and on day 5.

    Duration of mechanical ventilation

  3. ICU length of stay

    Time frame: After day 2 of ICU admission and on day 5.

    ICU length of stay

Sponsors and collaborators

Lead sponsor

Damanhour University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 19, 2022
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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