Analysis of Data and Development of Physical Function Assessment Indicators for Early Diagnosis and Monitoring Factors of Acquired Weakness in the Intensive Care Unit
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cohort Studies
- Sponsor
- Samsung Medical Center
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- MRC sum
- Status
- Enrolling By Invitation
- Last Updated
- last year
Overview
Brief Summary
Data Analysis and Physical Function Evaluation Index Development for Early Diagnosis and Monitoring of ICU-acquired weakness
Detailed Description
ICU-acquired weakness (ICU-AW) is a prevalent complication, occurring in more than 50% of ICU patients, and has severe long-term effects on patient outcomes. This condition not only prolongs the duration of hospital stay but also persists long after discharge, continuously impacting patients' health and quality of life. Therefore, monitoring, prevention, and rehabilitation of ICU-AW should not be limited to the ICU period but should continue after transfer to general wards and after discharge. This study aims to provide foundational data for developing a platform capable of continuously monitoring and delivering rehabilitation therapy for ICU-AW from ICU admission through the post-discharge period. Recent meta-analyses have shown that providing rehabilitation for ICU patients improves physical function at discharge, reduces ICU stay by 0.8 days, and shortens total hospital stay by 1.75 days. Additionally, it increases the distance patients can walk unassisted at discharge, the number of patients capable of standing, the duration of ventilator-free days, and the percentage of patients discharged home. Understanding the recovery process of ICU-AW as a continuum from ICU to post-discharge is essential, and the necessity of continuous rehabilitation throughout this process is evident. However, the challenge lies in implementing this in real-world practice. This study seeks to provide foundational data for developing personalized educational programs applicable to remote digital therapeutics in the future.
Investigators
Jong Geol Do
M.D, PhD, Assistant professor
Samsung Medical Center
Eligibility Criteria
Inclusion Criteria
- •Patients admitted to the ICU who are 19 years of age
- •Patients who did consent of the study
Exclusion Criteria
- •Patients with a history of peripheral nerve injury
- •Patients with a history of major surgery within the past 12 weeks or those expected to undergo major surgery during the trial period
- •Patients with a history of central nervous system disorders (e.g., stroke, spinal cord injury)
- •Patients with cognitive impairment that may interfere with the conduct of the study
- •Patients with Do Not Resuscitate (DNR) orders, brain lesions, Clinical Frailty Score (CFS) exceeding 4, or those who have undergone cardiopulmonary resuscitation
- •Patients confirmed to have metastatic cancer
Outcomes
Primary Outcomes
MRC sum
Time Frame: Within 72 hours of ICU admission
Total Score 60, 12-group muscles, each score 0-5. The Score below 48 is diagnosed a s ICU aquired weakness.
Grip strength
Time Frame: Within 72 hours of ICU admission
To assess forearm strength, grip strength is measured using a dynamometer. Two measurements are taken on both the left and right sides, and the average value is recorded.
FSS-ICU
Time Frame: Within 72 hours of ICU admission
Functional status Score for the4 Intensive Care Unit 5 Functional movement : Rolling / Supine to Sit / Sit to Stand / Sitting on the edge of the bed, Walking Each item is scored from 0 to 7 based on the level of assistance needed, with 0 indicating complete inability and 35 indicating independent function.
JH-highest mobility scale
Time Frame: Within 72 hours of ICU admission
There are a total of 8 stages : lying in bed(1pt) Limited to activities in bed only(2 pt) Sitting up in bed (3 pt) Sitting on a chair beside the bed(4 pt) Standing(5 pt) Walking 10 steps beside the bed(6pt) Walking more than 7 meters (7pt) Walking more than 76 meters (8 pt)
Body composition
Time Frame: Within 72 hours of ICU admission
Height, weight, BMI, body fat percentage, Muscle mass are measured using an InBody device
US ( muscle thickness)
Time Frame: Within 72 hours of ICU admission
Muscle Thickness for a total of 6 tems in the upper and lower limbs, swallowing muscles , is measured using ultrasound examination
Fitbit charge 5
Time Frame: During ICU status
Activity amount assessment The Fitbit Charge 5 is a wristband device equipped with an accelerometer that detects movement across three axes. It tracks information such as step count, distance traveled, calories burned, and active minutes, recording data from the time of wear until the battery depletes. This wearable device enables lifelogging through accelerometry. The Fitbit Charge 5 will be worn continuously from ICU admission upon study enrollment through to two weeks post-ICU discharge.
Nerve conduction study
Time Frame: Within 72 hours of ICU admission
IF Sarcopenia are met via Body Composition Assessment, nerve conduction study (NCS) is performed. NCS is conducted to evaluate peripheral nerve function and to determine the presence of peripheral neuropathy in this study. The nerve conduction study uses electrical stimulation to measure nerve conduction velocity, latency, and amplitude
Clinical Characteristics
Time Frame: Within 72 hours of ICU admission
Age,Diagnosis,CCI,Medical History,Education Level,Marital status
Secondary Outcomes
- MRC sum(Within 24 hours of ICU discharge)
- Grip strength(Within 24 hours of ICU admission)
- FSS-ICU(Within 24 hours of ICU discharge)
- JH-highest mobility scale(Within 24 hours of ICU discharge)
- Fitbit charge 5(Within 24 hours of ICU discharge)
- US -muscle thickness (T2)(Within 24 hours of ICU discharge)
- Body composition(T2)(Within 24 hours of ICU discharge)