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Electrical Muscle Stimulation in the Development of Acquired Weakness in Patients With Severe Sepsis and Septic Shock

Electrical Muscle Stimulation in the Development of Acquired Weakness in the Intensive Care Unit in Adult Patients With Severe Sepsis and Septic Shock at the Clinic Hospital of the Univerisity of Chile: Results of a Pilot Randomized Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03765489
Enrollment
23
Registered
2018-12-05
Start date
2016-11-18
Completion date
2018-06-21
Last updated
2018-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polyneuropathies, Septic Shock, Muscle Weakness

Keywords

polyneuropathies, muscle weakness, sepsis, septic shock, electrical stimulation, intensive care unit

Brief summary

The aim of this study is to compare the effect of EMS and conventional physical therapy on strength and muscle mass and development in adult patients with severe sepsis and septic shock.

Detailed description

Septic patients are at high risk of developing intensive care unit acquired weakness (ICUAW). Electrical muscle stimulation (EMS) has become an alternative exercise for critical and non-cooperative patients.

Interventions

electrical muscle stimulation: The parameters used in biceps were: 35 Hz, 250 μs and in quadriceps were: 50 Hz, 400 μs. In both, biphasic wave was used, 45 minutes of total work, 5 seconds of contraction and 10 seconds of relaxation and the intensity was adjusted to present a visible contraction

PROCEDUREconventional physical therapy

conventional physical therapy according to the adaptation of the Start to move protocol of Gosselink et al

Sponsors

University of Chile
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Subjects admitted to the ICU of the HCUCH in the period between November 2016 to August 2017 and January to June 2018 * Diagnosis of severe sepsis or septic shock * More than 48 hours in VMI * With sedation and / or neuromuscular blockade * Autovalent prior to admission to the ICU

Exclusion criteria

* Subjects from other hospitals / clinics or units of the hospital * Multiple trauma * Previous neuromuscular pathology * Pacemaker users * Pregnant women * BMI\> 35 * Epilepsy * Those who have refused to sign informed consent

Design outcomes

Primary

MeasureTime frameDescription
intensive care unit acquired weaknessat awakening of the subject, an average of 8 daysMedical research council sum score: Bilateral testing of 6 muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion). Ranges from 0 (total paralysis) to 60 (normal strength). Score under 48 points indicates intensive care unit acquired weakness

Secondary

MeasureTime frameDescription
muscle massat ICU admission of the subjet, at 48 hours post admission and at awakening of the subject, an average of 8 daysultrasonography
maximum inspiratory pressureat awakening of the subject, an average of 8 daysmaximum inspiratory pressure
days of mechanical ventilationan average of 11 daysnumber of days wirh mechanical ventilation
muscle strengthat awakening of the subject, an average of 8 daysMedical research council sum score: Bilateral testing of 6 muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion). Ranges from 0 (total paralysis) to 60 (normal strength).
days of ICU stayat ICU discharge, an average of 18 daysnumber of days in ICU
mortality at 28 daysat 28 days post ICU admissionmortality
gait ability at hospital dischargeat hospital discharge, an averange of 3 monthspresence or not of gait ability
Number of Participants with weaning failure48 hours post extubation dayNumber of Participants who presented reintubation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026