Mechanical Ventilation ComplicationNUMBERNMESNCT04382378
Effects of NMES in Critically Ill Patients
A study testing neuromuscular electrical stimulation in people with Mechanical Ventilation Complication and Muscle Weakness Condition, run by Escola Superior de Ciencias da Saude at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication, Muscle Weakness Condition, Covid19
- What is being tested?
- neuromuscular electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Secretaria de Saúde do Distrito Federal
Brasília, Federal District, 700000
Vinicius Silva, PhD, +55 61 20172145, viniciius.maldaner@escs.edu.br
About this study
Official 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.
Read the 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.
- Being tested
- neuromuscular electrical stimulation
- Keywords
- muscular atrophy, electric stimulation therapy, intensive care units
- Medical subject headings
- COVID-19, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuromuscular electrical stimulationDevice
Also called NMES, transcutenaous electrical nerve stimulation
application of an electric current through electrodes placed on the skin over the targeted musclesto induce skeletal muscle contractions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: neuromuscular electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
cross sectional area of rectus femoris
change of muscle wasting assessed by ultrassonogropahy
Measured: from baseline to 14 days of therapy
echointensity of rectus femoris
change of echointensity of rectus femoris assessed by ultrassonography
Measured: from baseline to 14 days of therapy
muscle strength
change of evoked peak torque of quadriceps femoris assesssed by unvolitional testing
Measured: from baseline to 14 days of therapy
Secondary outcomes (2)
Functional status
Functional status assessed by IMS scale ranged from 0 to 10
Measured: 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
Measured: from baseline to 14 days of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start1 Feb 2021
- Primary completion30 Sep 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Ciencias da Saude
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vinicius Zacarias Maldaner da silva, Escola Superior de Ciencias da Saude
- Investigators
- VINICIUS ZACARIAS MALDANER D SILVA, Principal investigator, Secretaria de Saúde do Distrito Federal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382378
- Sponsor's protocol ID
- FAP042017
- Acronym
- NUMBERNMES
- Status last verified
- Mar 2021
- First submitted
- 4 May 2020
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Regimen Protocols of NMES in COVID 19 Critically Ill Patients
- ClinicalTrials.gov ID
- NCT04382378
- Acronym / sponsor ID
- NUMBERNMES / FAP042017
- Keywords
- muscular atrophy, electric stimulation therapy, intensive care units
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Escola Superior de Ciencias da SaudeUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 11 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: neuromuscular electrical stimulationGroup 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. |
| 100 electrically evoked contractions | Experimental | Device: neuromuscular electrical stimulationGroup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neuromuscular electrical stimulationAlso: NMES, transcutenaous electrical nerve stimulationapplication of an electric current through electrodes placed on the skin over the targeted musclesto induce skeletal muscle contractions | Device | 100 electrically evoked contractions, 50 electrically evoked contractions |
Primary outcome
cross sectional area of rectus femoris
Time frame: from baseline to 14 days of therapy
change of muscle wasting assessed by ultrassonogropahy
echointensity of rectus femoris
Time frame: from baseline to 14 days of therapy
change of echointensity of rectus femoris assessed by ultrassonography
muscle strength
Time frame: from baseline to 14 days of therapy
change of evoked peak torque of quadriceps femoris assesssed by unvolitional testing
2 secondary outcomes
Functional status
Time frame: from baseline to 14 days of therapy
ICU acquired weakness
Time frame: from baseline to 14 days of therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
VINICIUS ZACARIAS MALDANER D SILVA principal investigator
Secretaria de Saúde do Distrito Federal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neuromuscular electrical stimulation in people with Mechanical Ventilation Complication and Muscle Weakness Condition, run by Escola Superior de Ciencias da Saude at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact VINICIUS ZACARIAS MALDANER D SILVA (6135462517, viniciusmaldaner@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cross sectional area of rectus femoris (time frame: from baseline to 14 days of therapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2021.