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Effects of NMES in Critically Ill Patients (NUMBERNMES)

Primary Purpose

Mechanical Ventilation Complication, Muscle Weakness Condition, Covid19

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
neuromuscular electrical stimulation
Sponsored by
Escola Superior de Ciencias da Saude
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mechanical Ventilation Complication focused on measuring muscular atrophy, electric stimulation therapy, intensive care units

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Secretaria de Saúde do Distrito FederalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

control group

50 electrically evoked contractions

100 electrically evoked contractions

Arm Description

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

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 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.

Outcomes

Primary Outcome Measures

cross sectional area of rectus femoris
change of muscle wasting assessed by ultrassonogropahy
echointensity of rectus femoris
change of echointensity of rectus femoris assessed by ultrassonography
muscle strength
change of evoked peak torque of quadriceps femoris assesssed by unvolitional testing

Secondary Outcome Measures

Functional status
Functional status assessed by IMS scale ranged from 0 to 10
ICU acquired weakness
percent of patients that have muscle strength assessed by Medical Research Council Sum-Score (MRC-SS) lower than 48

Full Information

First Posted
May 4, 2020
Last Updated
March 11, 2021
Sponsor
Escola Superior de Ciencias da Saude
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1. Study Identification

Unique Protocol Identification Number
NCT04382378
Brief Title
Effects of NMES in Critically Ill Patients
Acronym
NUMBERNMES
Official Title
Effects of Different Regimen Protocols of NMES in COVID 19 Critically Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Escola Superior de Ciencias da Saude

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Ventilation Complication, Muscle Weakness Condition, Covid19
Keywords
muscular atrophy, electric stimulation therapy, intensive care units

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The assessors will be blinded to randomization
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
Group that will receive a standard care from physiotherapy staff not involved in delivering the intervention whenever feasible.
Arm Title
50 electrically evoked contractions
Arm Type
Experimental
Arm Description
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.
Arm Title
100 electrically evoked contractions
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
neuromuscular electrical stimulation
Other Intervention Name(s)
NMES, transcutenaous electrical nerve stimulation
Intervention Description
application of an electric current through electrodes placed on the skin over the targeted musclesto induce skeletal muscle contractions
Primary Outcome Measure Information:
Title
cross sectional area of rectus femoris
Description
change of muscle wasting assessed by ultrassonogropahy
Time Frame
from baseline to 14 days of therapy
Title
echointensity of rectus femoris
Description
change of echointensity of rectus femoris assessed by ultrassonography
Time Frame
from baseline to 14 days of therapy
Title
muscle strength
Description
change of evoked peak torque of quadriceps femoris assesssed by unvolitional testing
Time Frame
from baseline to 14 days of therapy
Secondary Outcome Measure Information:
Title
Functional status
Description
Functional status assessed by IMS scale ranged from 0 to 10
Time Frame
from baseline to 14 days of therapy
Title
ICU acquired weakness
Description
percent of patients that have muscle strength assessed by Medical Research Council Sum-Score (MRC-SS) lower than 48
Time Frame
from baseline to 14 days of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
VINICIUS ZACARIAS MALDANER D SILVA
Phone
6135462517
Email
viniciusmaldaner@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
VINICIUS ZACARIAS MALDANER D SILVA
Organizational Affiliation
Secretaria de Saúde do Distrito Federal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Secretaria de Saúde do Distrito Federal
City
Brasilia
State/Province
DF
ZIP/Postal Code
700000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vinicius Silva, PhD
Phone
+55 61 20172145
Email
viniciius.maldaner@escs.edu.br

12. IPD Sharing Statement

Learn more about this trial

Effects of NMES in Critically Ill Patients

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