Electrical Stimulation to Reduce Length of Stay and Duration of Intubation in the Neurosciences-intensive Care Unit (NSICU)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Duration of Intubation
Study Overview
Brief 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.
Detailed Description
The purpose of this pilot trial is to estimate the effect of electrical stimulation (e-stim) to the bilateral quadriceps on duration of intubation, ICU and hospital length of stay, and functional recovery in the NSICU in comparison to historical matched controls. The objectives of this initial pilot and feasibility study are to estimate the effect size to power a future full scale randomized controlled trial of this intervention and to optimize study logistics for a future full scale trial. The specific aims of the trial are:
Specific Aim 1 - Feasibility: Determine whether at least 4 of 5 planned treatments can be performed as described, and whether there is adequate patient population meeting inclusion criteria available for study
Specific Aim 2 - Efficacy: Evaluate efficacy of e-stim by comparing length of ICU stay (days from admission to "intermediate level of care" ordered in Epic) and duration of intubation (days) of subjects to that of historical controls.
Specific Aim 3 - Exploratory: Evaluate functional recovery (measured by modified Rankin Scale [mRS] and Extended Glasgow Outcome Scale [GOSE] at NSICU discharge) of subjects compared to that of historical controls.
Hypothesis: The investigators hypothesize that e-stim treatments will reduce the length of hospital stay and intubation and improve functional recovery.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Electrical Stimulation Treatment
Patient will receive electrical stimulation to the quadriceps muscle groups on both lower extremities simultaneously for 45 minutes at a time, for a total of 5 treatments each week (Mon-Sun), for up to 14 days or until ICU discharge, whichever comes first.
Intervention: Electrical Stimulation Treatment (Device)
Electrical Stimulation Treatment
Patient will receive electrical stimulation to the quadriceps muscle groups on both lower extremities simultaneously for 45 minutes at a time, for a total of 5 treatments each week (Mon-Sun), for up to 14 days or until ICU discharge, whichever comes first.
Intervention: Neuromuscular Electrical Stimulation Treatment (Device)
Outcomes
Primary Outcomes
Duration of Intubation
Time Frame: Within 90 days
Duration of intubation in days
Secondary Outcomes
- Modified Rankin Scale(Within 90 days)
- Glasgow Outcome Scale - Extended(Within 90 days)
- Length of Hospital Stay(Within 90 days)
- Length of Neuroscience Intensive Care Unit Stay(Within 90 days)
Investigators
Michelle Cameron
Associate Professor of Neurology, School of Medicine
Oregon Health and Science University