Predictors of Prognosis in Patients With Critical Illness.

Completed

• Conditions: ICU Acquired Weakness; Weaning Failure; Quality of Life

• Registration Number: NCT04914065
• Lead Sponsor: Taoyuan General Hospital

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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-05-30
• Study First Posted: 2021-06-04
• Status Verified: 2021-07
• Primary Completion: 2021-07-13
• Study Completion: 2021-07-13
• Last Update Submitted: 2021-07-13
• Last Update Posted: 2021-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Part 2: Physical function at ICU discharge	conducted at the day of ICU discharge	2 mins walk test
Part 1: Change of diaphragm thickness from ICU admission to ICU discharge	every day during the ICU stay until patients discharge from ICU assessed up to 14 days	Muscle thickness of diaphragm and quadriceps detected by ultrasound(GE vivid S5)
Part 2: Change of General muscle strength	Baseline: admission to ICU in 48 hours. Progress: the day that patients received weaning profile test	Change of General muscle strength- MRC scale
Part 2: Change of Handgrip strength (HGS)	Baseline: admission to ICU in 48 hours. Progress: the day that patients received weaning profile test	Change of Handgrip strength (HGS) assessed by electronic hand dynamometer(Electronic hand dynamometer, CAMRY, MODEL, EH101)
Part 2: Respiratory muscle strength	the day that patient received weaning profile tests during ICU	Respiratory muscle strength- Maximal Inspiratory Pressure(MIP)
Part 2: Respiratory function	conducted at the day of ICU discharge	FVC, FEV1, FEV1/ FVC assessed by ezOxygen (EZO-G001)
Part 2: Change of Muscle mass	Baseline: admission to ICU in 48 hours. Progress: the day that patients received weaning profile test	Muscle thickness of diaphragm and quadriceps detected by ultrasound (GE vivid S5)
Part 2: Quality of life- SF-36(Taiwan version)	conducted by phone call at discharge for 6 months from ICU	SF-36(Taiwan version)
Part 1: Change of handgrip strength (HGS) from ICU admission to ICU discharge	every day during the ICU stay until patients discharge from ICU assessed up to 14 days	Handgrip strength (HGS) assessed by electronic hand dynamometer(Electronic hand dynamometer, CAMRY, MODEL, EH101)
Part 2: Change of Physical function	Baseline: admission to ICU in 48 hours. Progress: the day that patients received weaning profile test	Change of FSS-ICU
Part 2: Change of Delirium	conducted every day in the ICU	CAM-ICU

Trial Locations

Locations (1)

Department of Rehabilitation, Taoyuan General Hospital, Ministry of Health and Welfare, Taiwan; 🇨🇳 Taoyuan, Taiwan