Status:
COMPLETED
Use of Neuromuscular Electrostimulation (NMES) for Treatment or Prevention of ICU-Associated Weakness
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Intensive Care Unit
Muscle Weakness
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to investigate whether neuromuscular electrostimulation (NMES) will decrease ICU-associated weakness. The investigators believe that 60 minutes of daily NMES will improve ...
Detailed Description
Survivors of critical illness frequently have significant, debilitating and persistent weakness after discharge from the intensive care unit (ICU). This weakness can persist for up to 4 years after IC...
Eligibility Criteria
Inclusion
- 1 day of mechanical ventilation with an expectation of requiring ≥2 additional days of ICU stay in a Johns Hopkins Intensive Care Unit (ICU)
Exclusion
- Unable to understand or speak English due to language barrier or cognitive impairment prior to admission
- Unable to independently transfer from bed to chair at baseline prior to hospital admission
- Known primary systemic neuromuscular disease (e.g. Guillian-Barre) at ICU admission
- Known intracranial process that is associated with localizing weakness (e.g. cerebral vascular accident) at ICU admission
- Transferred from another ICU outside of the Johns Hopkins system after \>4 consecutive days of mechanical ventilation
- Moribund (i.e. \>90% probability of patient mortality in the next 96 hours)
- Anticipated transfer to another ICU for care (e.g. awaiting organ transplantation and transfer to surgical ICU)
- Any pacemaker (e.g., cardiac, diaphragm) or implanted cardiac defibrillator
- Pregnancy
- Body mass index ≥35 kg/m2
- Any limitation in life support other than a sole no-CPR order
- Known or suspected malignancy in the legs
- Unable to treat or evaluate both lower extremities (e.g., bilateral amputation, bilateral skin lesions)
- ICU length of stay \>7 days prior to enrollment
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00709124
Start Date
June 1 2008
End Date
April 1 2013
Last Update
January 23 2018
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287