Clinical trial NCT04914065: Predictors of Prognosis in Patients With Critical Illness.
Official title: Predictors of Prognosis in Patients With Critical Illness.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ICU Acquired Weakness
Weaning Failure
Quality of Life
Keywords: Intensive care unit acquired weakness
Handgrip strength
Muscle thickness
Predictor
Ventilator weaning
Quality of Life
Lead sponsor: Taoyuan General Hospital
Sponsor class: OTHER_GOV
Collaborators: name: National Yang Ming Chiao Tung University
name: Ministry of Science and Technology of the People´s Republic of China
First posted: 2021-06-04
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the surgery intensive care unit will be recruited and evaluated in 48 hours from admission to ICU

Brief summary: Recently, intensive care unit acquired weakness (ICUAW) has become a hotspot issue in the patients with critical illness. The symptoms of ICUAW, including sensory impairment and muscle atrophy, may lead to poor quality of life even though the patients discharged from the ICU for a long time. Therefore, an ounce of prevention is worth a pound of cure. At the same time, early evaluation is necessary to keep critically ill patients away from ICUAW. Medical Research Council (MRC) scale is the most common approach for diagnosis clinically. Regarding the interrater variation of MRC, handgrip strength (HGS) has been thought to be a simple and accurate alternative. However, HGS does not belong to antigravity or respiratory muscle which are the first to be affected by immobilization. It is still unknown whether HGS can represent the general muscle condition in ICU or not.

Additionally, previous studies have proved that patients with critical illness in the ICU would have better prognosis and less complications, if they undergo physical therapy as soon as possible. In addition to early ventilator weaning and reduced mortality rate, physical therapy could enhance quality of life (QoL) after patient discharges from hospital. However, early mobility in the ICU mainly emphasizes cardiopulmonary patients due to the traditional concept in Taiwan. Hence, the duration of mechanical ventilation in the critical patients will affect the timing to receive physical therapy, even impact the improvement of QoL.

Because of these reasons, this study will investigate the relationship between HGS and muscle mass among patients with critical illness and find the predictors of the short-term and long-term goals in the ICU, including ventilator weaning and QoL after hospital discharge.

Detailed description: This prospective and observational study will be divided into 2 parts: 1) The association between handgrip strength and muscle mass in intensive care unit patients. 2) Predictors of short-term and long-term goals in ICU.

Patients in the surgery intensive care unit of Taoyuan General Hospital will be recruited and evaluated in 48 hours from admission to ICU. The outcome measures include HGS assessed by electronic hand dynamometer and muscle thickness of diaphragm and quadriceps detected by ultrasound.

The short-term goal is weaning ventilator, and the long-term goal is quality of life after discharge from hospital assessed through SF-36 Taiwan version. Patients in the surgery intensive care unit of Taoyuan General Hospital will be recruited and evaluated in 48 hours after ICU admission. The collected data contain muscle strength, muscle mass, physical function, respiratory function, and observation of delirium or not. The evaluations of muscle strength include 3 parts which are limbs(handgrip), respiratory muscle(Maximal Inspiratory Pressure), and general muscle strength(Medical Research Council scale); Secondly, the evaluations of muscle mass divide 2 parts which are limbs(muscle thickness of quadriceps) and respiratory muscle(muscle thickness of diaphragm); Thirdly, the evaluations of physical function are 2 ways which are FSS-ICU and 2 mins walk test after discharge from the ICU; Fourthly, the evaluations of respiratory function contain 3 measurements of FEV1, FVC, and FEV1/FVC; Finally, the evaluation of delirium is assessed by CAM-ICU.

The statistical analysis will use SPSS version 24. Pearson correlation test will be conducted to investigate the association between HGS and muscle thickness. Multiple regression will be used to investigate the predictors for weaning ventilator successfully and quality of life after hospital discharge.

Eligibility criteria: Inclusion Criteria:

* Patients in the surgery intensive care unit will be recruited and evaluated in 48 hours from admission to ICU

Exclusion Criteria:

* Hemodynamic instability patients, e.g., patients with ECMO
* Patients refuse to participate this study

Primary outcomes:
measure: Part 1: Change of handgrip strength (HGS) from ICU admission to ICU discharge
timeFrame: every day during the ICU stay until patients discharge from ICU assessed up to 14 days
measure: Part 1: Change of diaphragm thickness from ICU admission to ICU discharge
timeFrame: every day during the ICU stay until patients discharge from ICU assessed up to 14 days
measure: Part 2: Change of Handgrip strength (HGS)
timeFrame: Baseline: admission to ICU in 48 hours. Progress: the day that patients received weaning profile test
measure: Part 2: Change of General muscle strength
timeFrame: Baseline: admission to ICU in 48 hours. Progress: the day that patients received weaning profile test
measure: Part 2: Change of Muscle mass
timeFrame: Baseline: admission to ICU in 48 hours. Progress: the day that patients received weaning profile test
measure: Part 2: Respiratory muscle strength
timeFrame: the day that patient received weaning profile tests during ICU
measure: Part 2: Change of Physical function
timeFrame: Baseline: admission to ICU in 48 hours. Progress: the day that patients received weaning profile test
measure: Part 2: Physical function at ICU discharge
timeFrame: conducted at the day of ICU discharge
measure: Part 2: Change of Delirium
timeFrame: conducted every day in the ICU
measure: Part 2: Respiratory function
timeFrame: conducted at the day of ICU discharge
measure: Part 2: Quality of life- SF-36(Taiwan version)
timeFrame: conducted by phone call at discharge for 6 months from ICU
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Department of Rehabilitation, Taoyuan General Hospital, Ministry of Health and Welfare, Taiwan
Study officials:
affiliation: Department of Rehabilitation, Taoyuan General Hospital, Ministry of Health and Welfare
name: Huan-Jui Yeh
role: STUDY_CHAIR
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