The ELMS Trial: ELectrical and Magnetic Stimulation to mitigate Intensive Care Unit-acquired weakness after trauma

Phase 2

Completed

• Conditions: ICU-acquired weakness; Musculoskeletal Diseases; Muscle wasting and atrophy, not elsewhere classified

• Registration Number: ISRCTN12562519
• Lead Sponsor: niversity of Birmingham (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-19
• Study Completion: 2014-04-01
• Last Update Posted: 30 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients must:
1. be aged 16 years old or over
2. have been able to transfer independently from bed to chair prior to injury
3. be admitted to the Critical Care Unit at Queen Elizabeth Hospital, Birmingham as result of traumatic injury
4. have an anticipated length of stay of at least 2 weeks
5. give consent (or, if lacking capacity at screening, have a personal or professional consultee indicate that they would be likely to give consent were they not lacking capacity)
Target Gender: Male & Female

Exclusion Criteria

Patients must not:
1. refuse to allow their GP to be informed of participation
2. have known systemic neuromuscular disease (e.g. Guillain Barré Syndrome) at ICU admission
3. have known pathology affecting the brain, causing weakness (e.g. stroke or bleeding in the brain) at the time of Critical Care Unit admission
4. have any pacemaker (e.g., cardiac, diaphragm, gastric) or implanted cardiac defibrillator, neurostimulator, intracardiac line or cochlear implant
5. have any metallic implants or foreign bodies in the areas to be stimulated
6. have any metal (other than titanium) in the head or brain
7. have known or suspected malignancy in any limb
8. be pregnant
9. have a body mass index =35 kg/m2
10. have been an critical care patient for more than 7 days prior to enrolment
11. be moribund (i.e. >90% probability of patient mortality in the next 96 hours)
12. have any limitation in life support at the time of enrolment other than an instruction not to attempt cardiopulmonary resuscitation in the event of cardiac arrest
13. have upper limb fractures

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Incidence of ICU-Acquired Weakness<br> Timepoint(s): Day after completion of intervention regimen or at first point where participant can be assessed<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Critical Care Unit and Hospital length of stay; Timepoint(s): At discharge from CCU and hospital<br> 2. Grip strength and MRC Sumscale of upper limb muscles; Timepoint(s): Day after completion of intervention or earliest point at which participant can be assessed<br> 3. Inflammatory profile during intervention; Timepoint(s): Day 0, 3, 6 and 10<br> 4. Interval to independent mobilisation; Timepoint(s): during hospital stay<br> 5. Interval to independent transfer from bed to chair; Timepoint(s): During hospital stay<br> 6. Muscle architecture; Timepoint(s): Biceps biopsy taken on day after completion of stimulation<br> 7. Nerve conduction studies; Timepoint(s): Day after completion of stimulation regimen<br> 8. Northwick Park Dependency Score; Timepoint(s): Hospital discharge<br> 9. Quality of Life; Timepoint(s): Hospital discharge and 6 months post- discharge<br>