Muscle Weakness or AtrophyNCT05536531
NMES Role to Prevent Respiratory Muscle Weakness in Critically Ill Patients and Its Association to Changes in Myokines.
A study testing Neuromuscular electrical stimulation (NMES) in people with Muscle Weakness or Atrophy and Mechanical Ventilation Complication, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
Particularly, muscle respiratory wasting will occur early (18 to 69 hours) in up to 60% of patients with mechanical ventilation (MV), leading rapidly to diaphragmatic weakness, which is associated with prolonged MV use, longer ICU and hospital stay, and higher mortality risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Weakness or Atrophy, Mechanical Ventilation Complication, Electrical Stimulations
- What is being tested?
- Neuromuscular electrical stimulation (NMES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChile
- Study dates
- 11 Jul 2022to 28 Feb 2025
- 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
- Consecutively admission to Christus ICU between March 2021 and December 2021.
- Connected to invasive MV within the previous 24-48 hours
- Deep sedation [non-cooperative state; Sedation-Agitation Scale (SAS) 1 or 2].
- ICU-acquired weakness risk (One of the following risk factors: the need for invasive MV, sepsis, hyperglycemia, APACHE II admission score >13 pts, use of corticosteroids, and/or muscle inactivity due to deep sedation).
- Written informed consent provided by patient/surrogate
Who cannot join
- Age < 18 years
- Pregnancy
- Obesity (Body Mass Index >35 kg/m2)
- Pre-existing Neuromuscular diseases (e.g., myasthenia Gravis, Guillain-Barré disease)
- Diseases with systemic vascular involvement such as systemic lupus erythematosus.
- Use of neuromuscular blockers
Show all 10Show fewer
- Technical obstacles to the implementation of NMES such as bone fractures or skin lesions (e.g., burns)
- End-stage malignancy
- Presence of cardiac pacemakers
- Diagnosis of brain death.
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Pontificia Universidad Católica de Chile
Santiago, Santiago Metropolitan, 8970117
Yorschua Jalil, PT, 96691771 ext. +569, yfjalil@uc.cl
Alejandro Bruhn, MD, alejandrobruhn@gmail.com
About this study
Official title: Role of Neuromuscular Electrical Stimulation to Prevent Respiratory Muscle Weakness in Critically Ill Patients and Its Association to Changes in Myokines Profile. A Randomized Clinical Trial.
Particularly, muscle respiratory wasting will occur early (18 to 69 hours) in up to 60% of patients with mechanical ventilation (MV), leading rapidly to diaphragmatic weakness, which is associated with prolonged MV use, longer ICU and hospital stay, and higher mortality risk. Sepsis and muscle inactivity, derived from sedation and MV use, are key driver mechanisms for developing these consequences, which can be avoided through early physical activation. However, exercise is limited at the early stages of care, where sedation and MV are needed, delaying muscle activation. Neuromuscular electrical stimulation (NMES) represents an alternative to achieve early muscle contraction in non-cooperative patients, being able to prevent local muscle wasting and, according to some reports, has the potential to shorten the time on MV, suggesting a systemic effect through myokines, a diverse range of cytokines and chemokines secreted by myocytes during muscle contraction. However, no studies have evaluated whether NMES applied to peripheral muscles can exert distant muscle effects over the diaphragm, ameliorating its weakness and if this protective profile is associated with myokine's change in ICU patients. This proposal comprises a randomized controlled study of NMES applied twice daily, for three days, compared to standard care (no NMES). Thirty-two patients will be recruited in the first 48 hours after MV and randomly assigned to the control group or NMES group (16 subjects each). Muscle characterization of quadriceps and diaphragm will be performed at baseline (Day 1, before the first NMES session) and after the last NMES session (morning of day 4). Myokine measurements [IL-1, IL-6, IL-15, Brain-Derived Neurotrophic Factor (BDNF), Myostatin and Decorin], through blood serum obtained from peripheric blood samples, will be performed just before starting NMES (T0) at the end of the session (T0.5), and 2 and 6 hours later (T2 and T6). These myokine curves will be repeated on days 1 and 3 at the first NMES session of the day. The Control group will be assessed in the same way and timing, except that blood samples will be at T0 and T6. Additionally, functional outcomes such as MV time and ICU length of stay will be registered for all patients at ICU discharge. Standard care won´t be altered.
Read the detailed description
Critically ill patients hospitalized at Intensive Care Units (ICU) are characterized by an accelerated muscle wasting, which leads to general muscle weakness and loss of physical functions even after discharge. Particularly, muscle respiratory wasting will occur early (18 to 69 hours) in up to 60% of patients with mechanical ventilation (MV), leading rapidly to diaphragmatic weakness, which is associated with prolonged MV use, longer ICU and hospital stay and higher mortality risk. Sepsis and muscle inactivity, derived from sedation and MV use, are key driver mechanisms to developing these negative consequences, which can be avoided through early physical activation. However, exercise is limited at early stages of care, where sedation and MV are needed, delaying muscle activation and favoring a vicious circle.
Neuromuscular electrical stimulation (NMES) represents an alternative to achieve early muscle contraction in non-cooperative patients, being able to prevent local muscle wasting and, according to some reports, has the potential to shorten the time on MV, suggesting a systemic effect through myokines, a diverse range of cytokines and chemokines secreted by myocytes during muscle contraction. These factors modulate the function and metabolism of distant organs and can promote muscle cell proliferation and growth in order to maintain muscle structure and function. However, no studies have evaluated whether NMES applied to peripheral muscles can exert distant muscle effects over the diaphragm, ameliorating its weakness, and if this protective profile is associated to myokine's change in critically ill patients.
We hypothesize that in mechanical ventilated ICU patients NMES contributes to prevent respiratory muscle weakness when initiated at an early phase of their critical illness, and this effect is associated to acute changes in myokine profile, being able to facilitate discontinuation of MV and decrease ICU length of stay.
This proposal comprises a randomized controlled study of NMES applied twice a day, for 3 days, in comparison to standard care (no NMES). Thirty-two patients will be recruited in the first 48 hours after connection to MV, and randomly assigned to either control group or stimulated group (16 subjects for each group). Muscle characterization of quadriceps and diaphragm (Structural ultrasonography evaluation of muscle thickness and tracheal twitch pressure assessment, derived from magnetic stimulation of phrenic nerve, for diaphragmatic strength) will be performed at baseline (Day 1, prior to the first NMES session) and after the last NMES session (morning of day 4). Myokine measurements (IL-1, IL-6, IL-15, BDNF, Myostatin and Decorin), through blood serum obtained from peripheric blood samples, will be performed at baseline 1 hour before NMES (T-1), just before starting NMES (T0), at the end of NMES session (T0.5), and 2 and 6 hours later (T2 and T6). This myokine curves will be repeated on days 1 and 3 at the first NMES session of the day. Control group will be assessed in the same way and timing, with the exception that blood samples will be performed at T0 and T6 of days 1 and 3. Additionally, functional outcomes such as MV time and ICU length of stay will be registered for all patients at ICU discharge. Standard care won´t be altered, performing passive mobilization according to ICU procedures in both groups.
- Being tested
- Neuromuscular electrical stimulation (NMES)
- Keywords
- Neuromuscular electrical stimulation, Critical care
- Medical subject headings
- Muscle Weakness, Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulation (NMES)Device
Also called Standard Care
Electrical stimulator (Electrostimulator TRAINFES 6 ADVANCED, Biomedical devices Spa, Santiago, Chile.) to administer NMES
| Study group | Role | What they receive |
|---|---|---|
| NMES group | Experimental | NMES will be implemented simultaneously on quadriceps femoris muscles of both lower limbs using an electrical stimulator (TRAINFES 6 ADVANCED, Biomedical devices Spa, Santiago, Chile). Four rubber surface electrodes will be placed over motor points. However, since the electrodes will cover big proportion of muscle surface, anatomical distribution of the belly muscle plus visible contraction of it will be considered for correct setting. The stimulation will be delivered by biphasic current, symmetric (compensated) impulses of 45-50 Hz frequency, 400 μsec pulse duration. With a stimulus duration of 25 minutes, and an on-off programming of 5 seconds on (including 0.8 second rise time, 3.4 seconds of plateau and 0.8 second of fall time) and 5 seconds off, at current intensities able to cause maximal visible contractions. The session duration will be 30 minutes and will be applied twice a day. Receives: Device: Neuromuscular electrical stimulation (NMES) |
| Control | No intervention | Sham NMES will not be provided. Standard care won´t be altered and passive mobilization will be performed according to routine ICU procedures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tracheal twitch pressure (centimeters of water)
Sub Maximal diaphragmatic strength measured trough tracheal twitch pressure derived from magnetic stimulation of phrenic nerve.
Measured: Change from begining (Day one) and at the end (Day three)
Change in Diaphragmatic thickness fraction (centimeter percentage change)
Diaphragmatic function derived from ultrasonography measurement of diaphragmatic muscle thickness between inspiration and expiration (during twitch manoeuvre)
Measured: Change from begining (Day one) and at the end (Day three)
Secondary outcomes (10)
IL-1 myokine
IL-1 Measured in peripheral blood samples (pg/dL)
Measured: through Study, at begining (Day one) and at the end (Day three). Before and after intervención
IL-6 myokine
IL-6 Measured in peripheral blood samples (pg/dL)
Measured: through Study, at begining (Day one) and at the end (Day three). Before and after intervención
Decorin myokine
Decorin Measured in peripheral blood samples (pg/dL)
Measured: through Study, at begining (Day one) and at the end (Day three). Before and after intervención
Myostatin myokine
Myostatin Measured in peripheral blood samples (pg/dL)
Measured: through Study, at begining (Day one) and at the end (Day three). Before and after intervención
IL-15 myokine
IL-15 Measured in peripheral blood samples (pg/dL)
Measured: through Study, at begining (Day one) and at the end (Day three). Before and after intervención
Brain derived neurotrophic Factor (BDNF) myokine
BDNF Measured in peripheral blood samples (pg/dL)
Measured: through Study, at begining (Day one) and at the end (Day three). Before and after intervención
Change in Diaphragmatic muscle structure (cemtimeters)
Diaphragmatic thickness measured with ultrasonography (Centimeters)
Measured: Change from begining (Day one) and at the end (Day three)
Change in peripheral muscle structure (centimeters)
Muscle layer thickness of vastus intermedius and rectus femoris of the quadriceps, measured with ultrasonography (Centimeters)
Measured: Change from begining (Day one) and at the end (Day three)
Functional outcomes
Mechanical Ventilation time (Hours)
Measured: through Study completion, an average of 1 month as maximum during follow up
Functional outcomes
ICU length of stay (Days)
Measured: through Study completion, an average of 2 month as maximum during follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start11 Jul 2022
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Muscle Weakness or AtrophyStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yorschua Jalil, PT, MSc, Principal investigator, Facultad de Medicina, Pontificia Universidad Católica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536531
- Sponsor's protocol ID
- 52-c50
- Other IDs
- ID 210602003
- Status last verified
- Jul 2024
- First submitted
- 20 Jul 2022
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan
Publications
Dres M, Dube BP, Mayaux J, Delemazure J, Reuter D, Brochard L, Similowski T, Demoule A. Coexistence and Impact of Limb Muscle and Diaphragm Weakness at Time of Liberation from Mechanical Ventilation in Medical Intensive Care Unit Patients. Am J Respir Crit Care Med. 2017 Jan 1;195(1):57-66. doi: 10.1164/rccm.201602-0367OC.
PubMed 27310484Goligher EC, Fan E, Herridge MS, Murray A, Vorona S, Brace D, Rittayamai N, Lanys A, Tomlinson G, Singh JM, Bolz SS, Rubenfeld GD, Kavanagh BP, Brochard LJ, Ferguson ND. Evolution of Diaphragm Thickness during Mechanical Ventilation. Impact of Inspiratory Effort. Am J Respir Crit Care Med. 2015 Nov 1;192(9):1080-8. doi: 10.1164/rccm.201503-0620OC.
PubMed 26167730Dirks ML, Hansen D, Van Assche A, Dendale P, Van Loon LJ. Neuromuscular electrical stimulation prevents muscle wasting in critically ill comatose patients. Clin Sci (Lond). 2015 Mar;128(6):357-65. doi: 10.1042/CS20140447.
PubMed 25296344Truong AD, Kho ME, Brower RG, Feldman DR, Colantuoni E, Needham DM. Effects of neuromuscular electrical stimulation on cytokines in peripheral blood for healthy participants: a prospective, single-blinded Study. Clin Physiol Funct Imaging. 2017 May;37(3):255-262. doi: 10.1111/cpf.12290. Epub 2015 Oct 16.
PubMed 26475418Routsi C, Gerovasili V, Vasileiadis I, Karatzanos E, Pitsolis T, Tripodaki E, Markaki V, Zervakis D, Nanas S. Electrical muscle stimulation prevents critical illness polyneuromyopathy: a randomized parallel intervention trial. Crit Care. 2010;14(2):R74. doi: 10.1186/cc8987. Epub 2010 Apr 28.
PubMed 20426834
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Neuromuscular Electrical Stimulation to Prevent Respiratory Muscle Weakness in Critically Ill Patients and Its Association to Changes in Myokines Profile. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05536531
- Acronym / sponsor ID
- 52-c50
- Keywords
- Neuromuscular electrical stimulation, Critical care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 13 Sep 2022 (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.
Particularly, muscle respiratory wasting will occur early (18 to 69 hours) in up to 60% of patients with mechanical ventilation (MV), leading rapidly to diaphragmatic weakness, which is associated with prolonged MV use, longer ICU and hospital stay, and higher mortality risk. Sepsis and muscle inactivity, derived from sedation and MV use, are key driver mechanisms for developing these consequences, which can be avoided through early physical activation. However, exercise is limited at the early stages of care, where sedation and MV are needed, delaying muscle activation. Neuromuscular electrical stimulation (NMES) represents an alternative to achieve early muscle contraction in non-cooperative patients, being able to prevent local muscle wasting and, according to some reports, has the potential to shorten the time on MV, suggesting a systemic effect through myokines, a diverse range of cytokines and chemokines secreted by myocytes during muscle contraction. However, no studies have evaluated whether NMES applied to peripheral muscles can exert distant muscle effects over the diaphragm, ameliorating its weakness and if this protective profile is associated with myokine's change in ICU patients. This proposal comprises a randomized controlled study of NMES applied twice daily, for three days, compared to standard care (no NMES). Thirty-two patients will be recruited in the first 48 hours after MV and randomly assigned to the control group or NMES group (16 subjects each). Muscle characterization of quadriceps and diaphragm will be performed at baseline (Day 1, before the first NMES session) and after the last NMES session (morning of day 4). Myokine measurements [IL-1, IL-6, IL-15, Brain-Derived Neurotrophic Factor (BDNF), Myostatin and Decorin], through blood serum obtained from peripheric blood samples, will be performed just before starting NMES (T0) at the end of the session (T0.5), and 2 and 6 hours later (T2 and T6). These myokine curves will be repeated on days 1 and 3 at the first NMES session of the day. The Control group will be assessed in the same way and timing, except that blood samples will be at T0 and T6. Additionally, functional outcomes such as MV time and ICU length of stay will be registered for all patients at ICU discharge. Standard care won´t be altered.
Detailed description
Critically ill patients hospitalized at Intensive Care Units (ICU) are characterized by an accelerated muscle wasting, which leads to general muscle weakness and loss of physical functions even after discharge. Particularly, muscle respiratory wasting will occur early (18 to 69 hours) in up to 60% of patients with mechanical ventilation (MV), leading rapidly to diaphragmatic weakness, which is associated with prolonged MV use, longer ICU and hospital stay and higher mortality risk. Sepsis and muscle inactivity, derived from sedation and MV use, are key driver mechanisms to developing these negative consequences, which can be avoided through early physical activation. However, exercise is limited at early stages of care, where sedation and MV are needed, delaying muscle activation and favoring a vicious circle.
Neuromuscular electrical stimulation (NMES) represents an alternative to achieve early muscle contraction in non-cooperative patients, being able to prevent local muscle wasting and, according to some reports, has the potential to shorten the time on MV, suggesting a systemic effect through myokines, a diverse range of cytokines and chemokines secreted by myocytes during muscle contraction. These factors modulate the function and metabolism of distant organs and can promote muscle cell proliferation and growth in order to maintain muscle structure and function. However, no studies have evaluated whether NMES applied to peripheral muscles can exert distant muscle effects over the diaphragm, ameliorating its weakness, and if this protective profile is associated to myokine's change in critically ill patients.
We hypothesize that in mechanical ventilated ICU patients NMES contributes to prevent respiratory muscle weakness when initiated at an early phase of their critical illness, and this effect is associated to acute changes in myokine profile, being able to facilitate discontinuation of MV and decrease ICU length of stay.
This proposal comprises a randomized controlled study of NMES applied twice a day, for 3 days, in comparison to standard care (no NMES). Thirty-two patients will be recruited in the first 48 hours after connection to MV, and randomly assigned to either control group or stimulated group (16 subjects for each group). Muscle characterization of quadriceps and diaphragm (Structural ultrasonography evaluation of muscle thickness and tracheal twitch pressure assessment, derived from magnetic stimulation of phrenic nerve, for diaphragmatic strength) will be performed at baseline (Day 1, prior to the first NMES session) and after the last NMES session (morning of day 4). Myokine measurements (IL-1, IL-6, IL-15, BDNF, Myostatin and Decorin), through blood serum obtained from peripheric blood samples, will be performed at baseline 1 hour before NMES (T-1), just before starting NMES (T0), at the end of NMES session (T0.5), and 2 and 6 hours later (T2 and T6). This myokine curves will be repeated on days 1 and 3 at the first NMES session of the day. Control group will be assessed in the same way and timing, with the exception that blood samples will be performed at T0 and T6 of days 1 and 3. Additionally, functional outcomes such as MV time and ICU length of stay will be registered for all patients at ICU discharge. Standard care won´t be altered, performing passive mobilization according to ICU procedures in both groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMES group | Experimental | Device: Neuromuscular electrical stimulation (NMES)NMES will be implemented simultaneously on quadriceps femoris muscles of both lower limbs using an electrical stimulator (TRAINFES 6 ADVANCED, Biomedical devices Spa, Santiago, Chile). Four rubber surface electrodes will be placed over motor points. However, since the electrodes will cover big proportion of muscle surface, anatomical distribution of the belly muscle plus visible contraction of it will be considered for correct setting. The stimulation will be delivered by biphasic current, symmetric (compensated) impulses of 45-50 Hz frequency, 400 μsec pulse duration. With a stimulus duration of 25 minutes, and an on-off programming of 5 seconds on (including 0.8 second rise time, 3.4 seconds of plateau and 0.8 second of fall time) and 5 seconds off, at current intensities able to cause maximal visible contractions. The session duration will be 30 minutes and will be applied twice a day. |
| Control | No intervention | –Sham NMES will not be provided. Standard care won´t be altered and passive mobilization will be performed according to routine ICU procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Consecutively admission to Christus ICU between March 2021 and December 2021.
- Connected to invasive MV within the previous 24-48 hours
- Deep sedation [non-cooperative state; Sedation-Agitation Scale (SAS) 1 or 2].
- ICU-acquired weakness risk (One of the following risk factors: the need for invasive MV, sepsis, hyperglycemia, APACHE II admission score >13 pts, use of corticosteroids, and/or muscle inactivity due to deep sedation).
- Written informed consent provided by patient/surrogate
Key exclusion criteria (10 listed)
- Age < 18 years
- Pregnancy
- Obesity (Body Mass Index >35 kg/m2)
- Pre-existing Neuromuscular diseases (e.g., myasthenia Gravis, Guillain-Barré disease)
- Diseases with systemic vascular involvement such as systemic lupus erythematosus.
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 stimulation (NMES)Also: Standard CareElectrical stimulator (Electrostimulator TRAINFES 6 ADVANCED, Biomedical devices Spa, Santiago, Chile.) to administer NMES | Device | NMES group |
Primary outcome
Change in Tracheal twitch pressure (centimeters of water)
Time frame: Change from begining (Day one) and at the end (Day three)
Sub Maximal diaphragmatic strength measured trough tracheal twitch pressure derived from magnetic stimulation of phrenic nerve.
Change in Diaphragmatic thickness fraction (centimeter percentage change)
Time frame: Change from begining (Day one) and at the end (Day three)
Diaphragmatic function derived from ultrasonography measurement of diaphragmatic muscle thickness between inspiration and expiration (during twitch manoeuvre)
10 secondary outcomes
IL-1 myokine
Time frame: through Study, at begining (Day one) and at the end (Day three). Before and after intervención
IL-6 myokine
Time frame: through Study, at begining (Day one) and at the end (Day three). Before and after intervención
Decorin myokine
Time frame: through Study, at begining (Day one) and at the end (Day three). Before and after intervención
Myostatin myokine
Time frame: through Study, at begining (Day one) and at the end (Day three). Before and after intervención
IL-15 myokine
Time frame: through Study, at begining (Day one) and at the end (Day three). Before and after intervención
Brain derived neurotrophic Factor (BDNF) myokine
Time frame: through Study, at begining (Day one) and at the end (Day three). Before and after intervención
Change in Diaphragmatic muscle structure (cemtimeters)
Time frame: Change from begining (Day one) and at the end (Day three)
Change in peripheral muscle structure (centimeters)
Time frame: Change from begining (Day one) and at the end (Day three)
Functional outcomes
Time frame: through Study completion, an average of 1 month as maximum during follow up
Functional outcomes
Time frame: through Study completion, an average of 2 month as maximum during follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Results publication: PubMed 27310484Dres M, Dube BP, Mayaux J, Delemazure J, Reuter D, Brochard L, Similowski T, Demoule A. Coexistence and Impact of Limb Muscle and Diaphragm Weakness at Time of Liberation from Mechanical Ventilation in Medical Intensive Care Unit Patients. Am J Respir Crit Care Med. 2017 Jan 1;195(1):57-66. doi: 10.1164/rccm.201602-0367OC.
- Results publication: PubMed 26167730Goligher EC, Fan E, Herridge MS, Murray A, Vorona S, Brace D, Rittayamai N, Lanys A, Tomlinson G, Singh JM, Bolz SS, Rubenfeld GD, Kavanagh BP, Brochard LJ, Ferguson ND. Evolution of Diaphragm Thickness during Mechanical Ventilation. Impact of Inspiratory Effort. Am J Respir Crit Care Med. 2015 Nov 1;192(9):1080-8. doi: 10.1164/rccm.201503-0620OC.
- Results publication: PubMed 25296344Dirks ML, Hansen D, Van Assche A, Dendale P, Van Loon LJ. Neuromuscular electrical stimulation prevents muscle wasting in critically ill comatose patients. Clin Sci (Lond). 2015 Mar;128(6):357-65. doi: 10.1042/CS20140447.
- Results publication: PubMed 26475418Truong AD, Kho ME, Brower RG, Feldman DR, Colantuoni E, Needham DM. Effects of neuromuscular electrical stimulation on cytokines in peripheral blood for healthy participants: a prospective, single-blinded Study. Clin Physiol Funct Imaging. 2017 May;37(3):255-262. doi: 10.1111/cpf.12290. Epub 2015 Oct 16.
- Results publication: PubMed 20426834Routsi C, Gerovasili V, Vasileiadis I, Karatzanos E, Pitsolis T, Tripodaki E, Markaki V, Zervakis D, Nanas S. Electrical muscle stimulation prevents critical illness polyneuromyopathy: a randomized parallel intervention trial. Crit Care. 2010;14(2):R74. doi: 10.1186/cc8987. Epub 2010 Apr 28.
- Individual participant dataSharing planned: No. No plan
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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.
Yorschua Jalil, PT, MSc principal investigator
Facultad de Medicina, Pontificia Universidad Católica de Chile
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 (NMES) in people with Muscle Weakness or Atrophy and Mechanical Ventilation Complication, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 5 inclusion and 10 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 14 Jan 2025. 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 Chile. 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 Yorschua Jalil, PT, MSc (96691771 ext. +56 9, yfjalil@uc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tracheal twitch pressure (centimeters of water) (time frame: Change from begining (Day one) and at the end (Day three)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05536531, which also lists 5 linked publications.
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 14 Jan 2025.