Covid19 Clinical Trial
— NUMBERNMESOfficial title:
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.
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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Secretaria de Saúde do Distrito Federal | Brasilia | DF |
Lead Sponsor | Collaborator |
---|---|
Escola Superior de Ciencias da Saude |
Brazil,
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 |
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