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NCT Number: NCT04914065

Predictors of Prognosis in Patients With Critical Illness.

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.

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Key information

Conditions

ICU Acquired Weakness Quality of Life Weaning Failure

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Taoyuan, 330, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regular care in the surgery intensive care unit

Other

Part 1: Two arms(muscle thickness observation):

  • Inspiratory muscles: diaphragm
  • Anti-gravity muscles: rectus femoris and the vastus intermedius

Part 2: Predictors of short-term and long-term goals in the ICU

  • Short-term goal: successful ventilator weaning in the ICU- pass weaning profile without re-intubation in the hospital
  • Long-term goal- Quality of life after hospital discharge: SF-36 (Taiwan version)

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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

  5. 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)

  6. Part 2: Respiratory muscle strength

    Time frame: the day that patient received weaning profile tests during ICU

    Respiratory muscle strength- Maximal Inspiratory Pressure(MIP)

  7. 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

  8. Part 2: Physical function at ICU discharge

    Time frame: conducted at the day of ICU discharge

    2 mins walk test

  9. Part 2: Change of Delirium

    Time frame: conducted every day in the ICU

    CAM-ICU

  10. Part 2: Respiratory function

    Time frame: conducted at the day of ICU discharge

    FVC, FEV1, FEV1/ FVC assessed by ezOxygen (EZO-G001)

  11. 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)

Sponsors and collaborators

Lead sponsor

Taoyuan General Hospital

Other Gov

Collaborators

  • Ministry of Science and Technology of the People´s Republic of China
  • National Yang Ming Chiao Tung University

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 4, 2021
Registry last updated
Jul 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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