Effects of NMES in Critically Ill Patients (NUMBERNMES)

Effects of Different Regimen Protocols of NMES in COVID 19 Critically Ill Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19; Muscle Weakness Condition; Mechanical Ventilation Complication
• Intervention / Treatment: Device: neuromuscular electrical stimulation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: VINICIUS ZACARIAS MALDANER D SILVA; Phone Number: 6135462517; Email: viniciusmaldaner@gmail.com

Study Locations

• Brazil
  • DF
    • Brasilia, DF, Brazil, 700000
      • Recruiting
      • Secretaria de Saúde do Distrito Federal
      • Contact: Vinicius Silva, PhD; Phone Number: +55 61 20172145; Email: viniciius.maldaner@escs.edu.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; Group that will receive a standard care from physiotherapy staff not involved in delivering the intervention whenever feasible.
Experimental: 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.	Device: neuromuscular electrical stimulation; application of an electric current through electrodes placed on the skin over the targeted musclesto induce skeletal muscle contractions; Other Names: NMES; transcutenaous electrical nerve stimulation
Experimental: 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.	Device: neuromuscular electrical stimulation; application of an electric current through electrodes placed on the skin over the targeted musclesto induce skeletal muscle contractions; Other Names: NMES; transcutenaous electrical nerve stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional status	Functional status assessed by IMS scale ranged from 0 to 10	from baseline to 14 days of therapy
ICU acquired weakness	percent of patients that have muscle strength assessed by Medical Research Council Sum-Score (MRC-SS) lower than 48	from baseline to 14 days of therapy

Collaborators and Investigators

• Sponsor: Escola Superior de Ciencias da Saude
• Investigators: Principal Investigator: VINICIUS ZACARIAS MALDANER D SILVA, Secretaria de Saúde do Distrito Federal

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 8, 2020
• First Posted (Actual): May 11, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2021
• Last Update Submitted That Met QC Criteria: March 11, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: intensive care units; muscular atrophy; electric stimulation therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; COVID-19; Muscle Weakness
• Other Study ID Numbers: FAP042017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No