Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06238609
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2024-01-25
Brief Title:
Neuromodulation for Prevention of Intensive Care Unit Acquired Weakness and Post Intensive Care Syndrome
Sponsor:
Bijan Najafi PhD
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Neuromodulation for Prevention of Intensive Care Unit Acquired Weakness and Post Intensive Care Syndrome
Status:
RECRUITING
Status Verified Date:
2024-02
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:
Post-intensive care syndrome PICS encompasses persistent physical cognitive and psychiatric symptoms following ICU discharge commonly triggered by serious conditions such as respiratory failure sepsis and mechanical ventilation PICS prevalence is reported to be as high as 84 up to 12 months in patients with at least 2 days spent in the ICU or with mechanical ventilatory support As a consequence many patients do not return to they former level of function for weeks months and even years
Muscular affection manifested by muscle weakness is particularly seen and is provoked by a combination of damage to the nerves or directly the muscles fibers This affection is referred to as CU-Acquired Weakness ICUAW One third of the time lower extremities are affected often due to prolonged immobilization or sedation Evidence suggests that early mobilization reduces the incidence of ICUAW at discharge and improves the number of patients able of stand However achieving this early intervention is not always feasible due to time or personnel constraints
The purpose of the study is to examine the effectiveness of lower extremity neuromodulation for prevention of muscle deconditioning in patients admitted to the ICU
Muscular affection manifested by muscle weakness is particularly seen and is provoked by a combination of damage to the nerves or directly the muscles fibers This affection is referred to as CU-Acquired Weakness ICUAW One third of the time lower extremities are affected often due to prolonged immobilization or sedation Evidence suggests that early mobilization reduces the incidence of ICUAW at discharge and improves the number of patients able of stand However achieving this early intervention is not always feasible due to time or personnel constraints
The purpose of the study is to examine the effectiveness of lower extremity neuromodulation for prevention of muscle deconditioning in patients admitted to the ICU
Detailed Description:
The purpose of the study is to examine feasibility and acceptability of lower extremity neuromodulation in patients at risk of ICUAW This is a proof Randomized controlled trial RCT study for prevention Eligible participants will be recruited from Baylor St Lukes Medical Center Houston Texas
Participants will be randomized to intervention group IG or control group CG The entire cohort will receive daily neuromodulation in the lower extremity Gastrocnemius muscle Achilles tendon up to 1 hour The therapy will be provided with a neuromodulation device Tennant Biomodulator PRO AVAZZIA Inc that works on high voltage alternative pulsed current The device will be functional for the IG and non-functional for the CG
Participants will be randomized to intervention group IG or control group CG The entire cohort will receive daily neuromodulation in the lower extremity Gastrocnemius muscle Achilles tendon up to 1 hour The therapy will be provided with a neuromodulation device Tennant Biomodulator PRO AVAZZIA Inc that works on high voltage alternative pulsed current The device will be functional for the IG and non-functional for the CG
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None