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N/A N=9 Treatment

Neurosciences-Intensive Care Unit Electrical Stimulation

Intensive Care (ICU) Myopathy

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

OutcomeResultp-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)
View full record on ClinicalTrials.gov →

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.

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