Clinical trial NCT06669494: Data Analysis and Physical Function Evaluation Index Development for Early Diagnosis and Monitoring of ICU-acquired Weakness
Official title: Analysis of Data and Development of Physical Function Assessment Indicators for Early Diagnosis and Monitoring Factors of Acquired Weakness in the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cohort Studies
ICU Acquired Weakness (ICUAW)
Critical Illness
Keywords: Post Intensive Care Syndrome(PICS)
Intensive Care Unit acquired weakness
Early mobilization
Digital Health Care Device
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Welfare
First posted: 2024-11-01
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to the MICU who are 19 years of age, SamsungMC

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.

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

Primary outcomes:
measure: MRC sum
timeFrame: Within 72 hours of ICU admission
measure: Grip strength
timeFrame: Within 72 hours of ICU admission
measure: FSS-ICU
timeFrame: Within 72 hours of ICU admission
measure: JH-highest mobility scale
timeFrame: Within 72 hours of ICU admission
measure: Body composition
timeFrame: Within 72 hours of ICU admission
measure: US ( muscle thickness)
timeFrame: Within 72 hours of ICU admission
measure: Fitbit charge 5
timeFrame: During ICU status
measure: Nerve conduction study
timeFrame: Within 72 hours of ICU admission
measure: Clinical Characteristics
timeFrame: Within 72 hours of ICU admission
Secondary outcomes:
measure: MRC sum
timeFrame: Within 24 hours of ICU discharge
measure: Grip strength
timeFrame: Within 24 hours of ICU admission
measure: FSS-ICU
timeFrame: Within 24 hours of ICU discharge
measure: JH-highest mobility scale
timeFrame: Within 24 hours of ICU discharge
measure: Fitbit charge 5
timeFrame: Within 24 hours of ICU discharge
measure: US -muscle thickness (T2)
timeFrame: Within 24 hours of ICU discharge
measure: Body composition(T2)
timeFrame: Within 24 hours of ICU discharge
Other outcomes:
measure: JH-highest mobility scale(T3)
timeFrame: After 2 weeks of GW admission
measure: MRC sum (T3)
timeFrame: After 2 weeks of GW admission
measure: Fitbit charge 5 (T3)
timeFrame: After 2 weeks of GW admission
measure: FSS-ICU(T3)
timeFrame: After 2 weeks of GW admission
measure: Grip strength(T3)
timeFrame: After 2 weeks of GW admission
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: