Effects of NMES in Critically Ill Patients

NCT04382378 | Unknown DMC

• 1 other identifier: FAP042017
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mechanical Ventilation Complication; Muscle Weakness Condition; Covid19

Keywords

muscular atrophy; electric stimulation therapy; intensive care units

Outcome Measures

Primary Outcomes (3)

• cross sectional area of rectus femoris

  change of muscle wasting assessed by ultrassonogropahy

  from baseline to 14 days of therapy

• echointensity of rectus femoris

  change of echointensity of rectus femoris assessed by ultrassonography

  from baseline to 14 days of therapy

• muscle strength

  change of evoked peak torque of quadriceps femoris assesssed by unvolitional testing

  from baseline to 14 days of therapy

Secondary Outcomes (2)

• Functional status

  from baseline to 14 days of therapy

• ICU acquired weakness

  from baseline to 14 days of therapy

Study Arms (3)

control group

NO INTERVENTION

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

50 electrically evoked contractions

EXPERIMENTAL

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.

Device: neuromuscular electrical stimulation

100 electrically evoked contractions

EXPERIMENTAL

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.

Device: neuromuscular electrical stimulation

Interventions

neuromuscular electrical stimulation DEVICE

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

Also known as: NMES, transcutenaous electrical nerve stimulation

100 electrically evoked contractions; 50 electrically evoked contractions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Escola Superior de Ciencias da Saude: lead

Study Sites (1)

Secretaria de Saúde do Distrito Federal

Brasília, Federal District, 700000, Brazil

RECRUITING

MeSH Terms

Conditions

COVID-19; Muscular Atrophy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• VINICIUS ZACARIAS MALDANER D SILVA

  Secretaria de Saúde do Distrito Federal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

VINICIUS ZACARIAS MALDANER D SILVA

CONTACT

6135462517; viniciusmaldaner@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessors will be blinded to randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Inverstigator

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 11, 2020
• Study Start: February 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: December 31, 2021
• Last Updated: March 15, 2021

Record last verified: 2021-03

Locations

BR (1)