Effects of NMES in Critically Ill Patients

Covid19 Clinical Trial

— NUMBERNMES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04382378
• Other study ID #: FAP042017
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2021
• Source: Escola Superior de Ciencias da Saude
• Contact: VINICIUS ZACARIAS MALDANER D SILVA
• Phone: 6135462517
• Email: viniciusmaldaner[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid19
• Mechanical Ventilation Complication
• Muscle Weakness
• Muscle Weakness Condition

Intervention

Device:
• neuromuscular electrical stimulation
application of an electric current through electrodes placed on the skin over the targeted musclesto induce skeletal muscle contractions

Locations

Country	Name	City	State
Brazil	Secretaria de Saúde do Distrito Federal	Brasilia	DF

Sponsors (1)

Lead Sponsor	Collaborator
Escola Superior de Ciencias da Saude

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cross sectional area of rectus femoris	change of muscle wasting assessed by ultrassonogropahy	from baseline to 14 days of therapy
Primary	echointensity of rectus femoris	change of echointensity of rectus femoris assessed by ultrassonography	from baseline to 14 days of therapy
Primary	muscle strength	change of evoked peak torque of quadriceps femoris assesssed by unvolitional testing	from baseline to 14 days of therapy
Secondary	Functional status	Functional status assessed by IMS scale ranged from 0 to 10	from baseline to 14 days of therapy
Secondary	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