Neurosciences-Intensive Care Unit Electrical Stimulation
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|ClinicalTrials.gov Identifier: NCT03547687|
Recruitment Status : Not yet recruiting
First Posted : June 6, 2018
Last Update Posted : June 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Intensive Care (ICU) Myopathy||Device: Electrical Stimulation Treatment||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Electrical Stimulation to Reduce Length of Stay and Duration of Intubation in the Neurosciences-intensive Care Unit (NSICU)|
|Estimated Study Start Date :||July 2018|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: 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.
Device: Electrical Stimulation Treatment
An Intelect Neuromuscular Electrical Stimulator (NMES) (Chattanooga Group) device will be used to provide the stimulation. The stimulator will be set up and taken off the patients by a member of the study team or a trained ICU staff member. The stimulation parameters will be as follows:
Electrode location: Proximal and distal quadriceps Waveform: pulsed biphasic Pulse duration: 300 microseconds Pulse frequency: 35 pulses per second Amplitude: palpable, visible quadriceps muscle contraction On/off time: 5 seconds on, 15 seconds off Ramp up and down time: 2 seconds each
- Duration of intubation [ Time Frame: Within 90 days ]Duration of intubation in days
- Length of NSICU stay [ Time Frame: Within 90 days ]Calculated based on date of admission to NSICU and date of transfer from NSICU
- Length of hospital stay [ Time Frame: Within 90 days ]Calculated based on date of admission to hospital and date of discharge from hospital
- Modified Rankin Scale [ Time Frame: Within 90 days ]Modified Rankin Scale at NSICU transfer, assessed by Nurse Practitioner. Measures degree of disability in patients after neurologic injury. Scale range is 0-6, higher value is a worse outcome.
- Glasgow Outcome Scale - Extended [ Time Frame: Within 90 days ]Glasgow Outcome Scale - Extended at NSICU transfer, assessed by Nurse Practitioner. Measures global functional outcomes after neurologic injury. Scale range is 1-8, higher value is a better outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547687
|Contact: Holly Hinson, MD, MCRemail@example.com|
|Contact: Emma Ricklesfirstname.lastname@example.org|
|Principal Investigator:||Michelle Cameron, MD, PT, MCR||Oregon Health and Science University|