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Predictors of Prognosis in Patients With Critical Illness.

13 de julho de 2021 atualizado por: 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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Real)

400

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

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

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Part 1: Change of handgrip strength (HGS) from ICU admission to ICU discharge
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: conducted at the day of ICU discharge
2 mins walk test
conducted at the day of ICU discharge
Part 2: Change of Delirium
Prazo: conducted every day in the ICU
CAM-ICU
conducted every day in the ICU
Part 2: Respiratory function
Prazo: 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)
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Cadeira de estudo: Huan-Jui Yeh, Department of Rehabilitation, Taoyuan General Hospital, Ministry of Health and Welfare

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de janeiro de 2020

Conclusão Primária (Real)

13 de julho de 2021

Conclusão do estudo (Real)

13 de julho de 2021

Datas de inscrição no estudo

Enviado pela primeira vez

25 de maio de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

30 de maio de 2021

Primeira postagem (Real)

4 de junho de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

19 de julho de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

13 de julho de 2021

Última verificação

1 de julho de 2021

Mais Informações

Termos relacionados a este estudo

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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