Ignite Creation Date:
2024-05-06 @ 6:04 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05536531
Status:
UNKNOWN
Last Update Posted:
2022-09-13
First Post:
2022-07-20
Brief Title:
NMES Role to Prevent Respiratory Muscle Weakness in Critically Ill Patients and Its Association to Changes in Myokines
Sponsor:
Pontificia Universidad Catolica de Chile
Organization:
Pontificia Universidad Catolica de Chile
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 myokines 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 T05 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 wont 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 myokines 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 T05 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 wont be altered performing passive mobilization according to ICU procedures in both groups
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 myokines 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 T05 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 wont be altered performing passive mobilization according to ICU procedures in both groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ID 210602003 | OTHER_GRANT | Health Science Department Grant IV-2020 | None |