Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409611
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-05-07
Brief Title:
MUSCLE EFFECTS OF NEUROMUSCULAR ELECTROSTIMULATION IN MECHANICALLY VENTILATED PATIENTS IN AN ICU
Sponsor:
Universidade Federal do Rio de Janeiro
Organization:
Universidade Federal do Rio de Janeiro
Study Overview
Official Title:
MUSCLE EFFECTS OF NEUROMUSCULAR ELECTROSTIMULATION IN MECHANICALLY VENTILATED PATIENTS IN AN ICU
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
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:
To prevent the development of ICUAW both early mobilization and neuromuscular electrical stimulation NMES have been shown to prevent muscle atrophy in critically ill patients by preserving muscle mass Furthermore it is of great value that muscle assessment using kinesiological ultrasound becomes routine to monitor this patients profile with regard to strength muscle quality and muscle mass Our objective is to evaluate the muscular changes promoted by NMES in patients under mechanical ventilation This is a randomized clinical trial study which will perform NMES sessions for at least 10 days in mechanically ventilated patients They will also undergo ultrasound assessments of the quadriceps Patients will be divided into a control group and an NMES group In addition general information recorded in the medical record will be collected such as basic characteristics laboratory tests and general assessments
Detailed Description:
This is a randomized clinical trial study which will be carried out at the Hospital Universitário Pedro Ernesto between the months of May 2024 and November 2025 where patients admitted to the General CTI will undergo muscle assessments through ultrasound and a protocol of NMES over a period of 10 days Participants will be randomized and allocated into 2 groups placebo and NMES After randomization general information recorded in the medical record will be collected such as baseline characteristics laboratory tests general assessments Sequential Organ Failure Assessment Score SOFA Chelsea Critical Care Physical Assessment Tool CPAx functional scale edema classification quality and type of contraction during each NMES session days on pressure support ventilation PSV and pressure or volume assist-controlled ventilation PCV or VCV use of neuromuscular blocker corticosteroids vasoactive amine and the type and days of diet Patients will undergo ultrasound evaluation of the pennation angle AP of the vastus lateralis cross-sectional area CSA of the rectus femoris thickness ESP of the quadriceps and echogenicity ECHO of the rectus femoris within the first 24h post intubation at 5 days and 10 days post intubation Muscle assessment was carried out by professional physiotherapists trained and certified for this purpose For the NMES group NMES therapy will be performed for 1 hour once a day and for 10 days Using the following parameters Biphasic and symmetrical rectangular pulse with a frequency of 50Hz pulse width of 500μs ON time of 10 seconds OFF time of 15 seconds 3 seconds of rise time and 2 seconds of descent time The intensity is increased to the point that there is complete muscle contraction visible or palpable The maximum intensity will be 120 mA
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