Effects of NMES in Critically Ill Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Muscle wasting occurred early and rapidly in critically ill patients. Early therapeutic strategies to either maintain muscle structure and function should be encouraged. Neuromuscular electrical stimulation (NMES) is an attractive intervention to maintain muscle mass and strength in critically ill patients during the first week of ICU stay. This study will test the hypothesis that the number of contraction per day evoked by NMES in the first two weeks of illness may influence in muscle wasting, with beneficial effects on the physical and functional status in mechanically ventilated patients.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Neuromuscular Electrical Stimulation (NMES) Preserves Muscle Mass in Intensive Care Unit (ICU)

NCT05287919

Critical Illness Physical Disability Muscle Atrophy

COMPLETED NA

Effects of Neuromuscular Electrical Stimulation on Critically Ill Patients With Mechanical Ventilation

NCT05217511

Respiratory Insufficiency Requiring Mechanical Ventilation

UNKNOWN NA

Bed Rest and Muscle Strength in ICU: Interest in the Early Association of NEMS With Cyclo-ergometer Mobilization

NCT03987997

Weakness, Muscle

UNKNOWN NA

NMES Role to Prevent Respiratory Muscle Weakness in Critically Ill Patients and Its Association to Changes in Myokines.

NCT05536531

Muscle Weakness or Atrophy Mechanical Ventilation Complication Electrical Stimulations

RECRUITING NA

The Effect of Neuromuscular Electrical Stimulation

NCT00442728

Postoperative Coronary Artery Bypass Grafting (CABG) Chronic Obstructive Pulmonary Disease (COPD) Ventilatory Failure

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients with prolonged mechanical ventilation require deep sedation and mechanical ventilation, factors predisposing to the development of skeletal muscle wasting and acute muscle atrophy. Strategies to attenuate this process must be used. The neuromuscular electrostimulation (NMES) leads to the application of electrical currents in the skin aiming at muscle contraction, has beneficial effects for the population of critical patients. However, the number of contractions induced by NMES to attenuate the loss of muscle mass in this population is not yet established. This randomized controlled trial with 120 patients that will be randomized to one of the 3 study groups: 100 continuous daily contractions (100Cd), 50 continuous daily contractions (50Cd) and control group. Muscle thickness, NMES-induced strength, and clinical and functional parameters at the time of discharge from the ICU and hospital discharge will be assessed daily. The results of this project will provide an important contribution to the understanding of the mechanisms associated with NMES treatment as a tool to minimize the effects of muscle disuse, as well as providing scientific support for the clinical use of this resource in the treatment in the light of the policies' health system.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mechanical Ventilation Complication Muscle Weakness Condition Covid19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The assessors will be blinded to randomization

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

control group

Group that will receive a standard care from physiotherapy staff not involved in delivering the intervention whenever feasible.

Group Type NO_INTERVENTION

No interventions assigned to this group

50 electrically evoked contractions

Group that will receive a standard care from physiotherapy staff plus neuromuscular electrical stimulation with the following parameters: pulsed current; freqeuncy 50Hz; pulse witdh 400 us, current intensity that get level 4/5 of evoked contractions proposed by Segers et al; on/off time and duration of therapy that allow 50 ellectrically evoked contractions with surface electrodes positioned on the quadriceps femoris.

Group Type EXPERIMENTAL

neuromuscular electrical stimulation

Intervention Type DEVICE

application of an electric current through electrodes placed on the skin over the targeted musclesto induce skeletal muscle contractions

100 electrically evoked contractions

Group that will receive a standard care from physiotherapy staff plus neuromuscular electrical stimulation with the following parameters: pulsed current; freqeuncy 50Hz; pulse witdh 400 us, current intensity that get level 4/5 of evoked contractions proposed by Segers et al; on/off time and duration of therapy that allow 100 ellectrically evoked contractions with surface electrodes positioned on the quadriceps femoris.

Group Type EXPERIMENTAL

neuromuscular electrical stimulation

Intervention Type DEVICE

application of an electric current through electrodes placed on the skin over the targeted musclesto induce skeletal muscle contractions

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

neuromuscular electrical stimulation

application of an electric current through electrodes placed on the skin over the targeted musclesto induce skeletal muscle contractions

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

NMES transcutenaous electrical nerve stimulation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Aged 18 years or older
* Intubated and expected to remain invasively mechanically ventilated the day after tomorrow
* laboratory confirmed COVID-19 (diagnosis of SARS-CoV-2 via reverse transcriptase polymerase chain reaction as per the World Health Organization protocol or by nucleic acid based isothermal amplification)

Exclusion Criteria

* Dependent for activities of daily living in the month prior to current ICU admission (gait aids are acceptable).
* Documented cognitive impairment.
* Proven or suspected spinal cord injury or other neuromuscular disease that will result in permanent or prolonged weakness (not including ICU acquired weakness)
* Death is deemed inevitable as a result of the current illness and either the patient or treating clinical or substitute decision maker are not committed to full active treatment
* pregnancy
* patients with unstable fractures in the vertebral column and lower limbs.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No