N/A
N=9
Neurosciences-Intensive Care Unit Electrical Stimulation
Intensive Care (ICU) Myopathy
Bottom Line
View on ClinicalTrials.gov: NCT03547687 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Duration of Intubation — 10.22 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Electrical Stimulation Treatment (Device); Neuromuscular Electrical Stimulation Treatment (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Intubation |
10.22 | — |
| SECONDARY Length of Neuroscience Intensive Care Unit Stay |
13.67 | — |
| SECONDARY Length of Hospital Stay |
29.56 | — |
| SECONDARY Modified Rankin Scale |
4.33 | — |
| SECONDARY Glasgow Outcome Scale - Extended |
3.44 | — |
Summary
Patients admitted to the Neurosciences Intensive Care Unit (NSICU) are at particular risk of developing ICU-associated weakness and myopathy, given the unique risks of early mobilization in these patients, which include increased intracranial pressure, hemodynamic instability, vasospasm, decreased cerebral blood flow with resultant cerebral ischemia, and delirium. Interventions that could provide some of the benefits of early mobilization without these risks would be of great utility in the NSICU. A number of studies have demonstrated that electrical stimulation of the lower extremity muscles, generally the quadriceps, can retard disuse atrophy and loss of strength associated with medical ICU stays, and one study has shown reduced length of intubation and accelerated functional recovery. This pilot trial will evaluate the impact of electrical stimulation on patients in the NSICU, with a hypothesis that electrical stimulation treatments will reduce the length of hospital stay and intubation and improve functional recovery. In this trial, intubated patients admitted to the NSICU will have electrical stimulation applied to the quadriceps muscle groups on both lower extremities simultaneously for 45 minutes at a time for a total of 5 treatments each week, for up to 14 days or until ICU discharge, whichever comes first.
Eligibility Criteria
Inclusion Criteria
- Admission to the NSICU for care for a neurologic illness requiring critical care
- Mechanically ventilated at time of enrollment
- Prognosis for prolonged ICU stay and/or prolonged intubation as evidenced by at least one pre-morbid risk factor: age ≥ 65 years, major medical co-morbidity (ex: heart failure, chronic obstructive pulmonary disease, chronic renal insufficiency, diabetes, poorly controlled hypertension, etc.), or severe acute critical illness (APACHE II >12)
Exclusion Criteria
- Contraindications to electrical stimulation - demand cardiac pacemaker, implanted cardiac defibrillator, deep brain stimulator, adhesive allergy, pregnancy
- Agitation such that the individual is at risk for pulling off the self-adhesive electrodes
- Moribund prognosis (not expected to survive >48 hours, initiation of comfort measures only)
- Severe peripheral edema
- Receiving vasopressors at the time of enrollment, or hemodynamically unstable
- Severe peripheral neuropathy (ex: acute inflammatory polyneuropathy)
- Receiving paralytic drug(s)
Data sourced from ClinicalTrials.gov (NCT03547687). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.