Predictors of Prognosis in Patients With Critical Illness.

July 13, 2021 updated by: Taoyuan General Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 330
        • Department of Rehabilitation, Taoyuan General Hospital, Ministry of Health and Welfare, Taiwan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taoyuan General Hospital

Collaborators

National Yang Ming University
Ministry of Science and Technology, R.O.C.

Investigators

  • Study Chair: Huan-Jui Yeh, Department of Rehabilitation, Taoyuan General Hospital, Ministry of Health and Welfare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

July 13, 2021

Study Completion (Actual)

July 13, 2021

Study Registration Dates

First Submitted

May 25, 2021

First Submitted That Met QC Criteria

May 30, 2021

First Posted (Actual)

June 4, 2021

Study Record Updates

Last Update Posted (Actual)

July 19, 2021

Last Update Submitted That Met QC Criteria

July 13, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TYGH108031

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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