CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 9 enrolled
Drug / intervention
Electrical Stimulation Treatment +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03547687
NCT03547687N/ACompleted

Electrical Stimulation to Reduce Length of Stay and Duration of Intubation in the Neurosciences-intensive Care Unit (NSICU)

Oregon Health and Science University·interventional·Posted Jun 6, 2018·Updated Feb 24, 2021

In Brief

A clinical study evaluating Electrical Stimulation Treatment and Neuromuscular Electrical Stimulation Treatment for Intensive Care (ICU) Myopathy. Completed, enrolled 9 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 6, 2018
Enrollment StartAug 10, 2018
Primary CompletionDec 31, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 8.1 years ago

Interventions

Electrical Stimulation Treatmentdevice

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

Neuromuscular Electrical Stimulation Treatmentdevice

If a muscle contraction is not produced with the Intelect NMES portable device, the Vectra Neo Clinical Therapy System (Chattanooga Group) device will be used instead. 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: 10 seconds on, 30 seconds off Ramp up and down time: 2 seconds each