Functional Recovery Over the First Year After ICU Discharge
Functional Recovery Over the First Year After ICU Discharge：How ICU-delirium and ICU-acquired Weakness Interact
Visão geral do estudo
Status
Descrição detalhada
For this 3-year cohort study, consecutive ICU stay over 24 hours and adult patients (≧20 years) will be screened for enrollment at 6 medical ICUs in the National Taiwan University Hospital. Participants will be assessed daily for delirium occurrence for up to 14 days of ICU stay, and again upon ICU discharge. The instrument used for delirium are the confusion assessment method for ICU (CAM-ICU) and the intensive care delirium screening checklist (ICDSC). The 7 point rating scale of CAM-ICU-7 will also be used to rate the severity of delirium. Delirium assessment is possible,if the the patient's Richmond Agitation and Sedation Scale (RASS, -5~+4) is ≧ -3, -4~-5 are deeper levels of sedation (unarousable or responsive to painful stimulation only) cannot be assessed accurately. The CAM-ICU comprises four features which assess the following: acute change or fluctuation in mental status (Feature 1), inattention (Feature 2), disorganized thinking (Feature 3) or an altered level of consciousness (Feature 4). Patients are considered to have delirium if they present with both the first (acute onset and fluctuating course) and second (inattention) core symptoms and either the third (altered consciousness) or fourth (disorganized thinking) symptom. The ICDSC comprises eight items (score 0-8), ICDSC score of 4 or higher are considered delirium.
At ICU discharge,assess ICU-AW using a standardized protocol. Participants will be followed for one year after ICU discharge at 1, 3, 6, 12 months. A comprehensive functional evaluation (6-minute walking test, grip strength test, maximum inspiratory pressure test, mini-mental state exam, physical function ICU test score and basic and instrument activities of daily living questionnaires, medical research council scale and medical research council questionnaire) will be completed. Estimated 158 participants will be enrolled and followed for one year.
Data will be analyzed using the SPSS package. For example, the Generalized Estimating Equation (GEE) will be performed to delineate the trajectory of physical functions one year after ICU discharge and to test the interaction among ICU-AD, ICU-AW, and one-year functional trajectories. The findings will add to the development of intervention program to reduce ICU-AD and ICU-AW, thus promoting functional recovery for ICU survivors.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Taipei City, Taiwan, 10055
- National Taiwan University Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Patient who is 20 years or older.
Exclusion Criteria:
- patients who presented with preexisting delirium at ICU admission
- patients who were placed on contact and droplet precaution
- patient who is long-term bedridden, moderate to severe dementia
- expected ICU length of stay less than 24 hours
- unable to communicate in Mandarin or Taiwanese
- unable to follow command completely
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Change from baseline 6-min walking distance to one year after ICU discharge
Prazo: Baseline at ICU discharge one month. One,two, three,six month and one year after ICU discharge
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Measured by distance walked in 6 minutes(6MWT) in meter, range from 400 to 700 meters, higher value indicated better global health condition
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Baseline at ICU discharge one month. One,two, three,six month and one year after ICU discharge
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Change from baseline hand grip strength to one year after ICU discharge
Prazo: Baseline at ICU discharge. One, two, three,six month and one year after ICU discharge
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Measured by hand grip strength (HGS) in kg, range from 20 to 65 kg, higher value indicated better musculoskeletal function
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Baseline at ICU discharge. One, two, three,six month and one year after ICU discharge
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Maximum inspiratory pressure, from baseline to one year after ICU discharge
Prazo: Baseline at ICU discharge one month. Two, three, six month and one year after ICU discharge
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Measured by maximum inspiratory pressure (MIP test ) in cmH2O, normal range < -20 cmH2O, lower value indicated better respiratory muscle condition
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Baseline at ICU discharge one month. Two, three, six month and one year after ICU discharge
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Change from baseline Mini-Mental State Examination to one year after ICU discharge
Prazo: Baseline at ICU discharge. One, two, three, six month and one year after ICU discharge
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Measured by Mini-Mental State Examination (MMSE) in score, range from 0 to 30 score, higher score indicated better cognitive function
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Baseline at ICU discharge. One, two, three, six month and one year after ICU discharge
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Physical function, from baseline to 3 months after ICU discharge
Prazo: Baseline at ICU discharge. One, two and three month after ICU discharge
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Measured by Physical function ICU test score (PFITs) in score, range from 0 to 10 score, higher score indicated better health condition.
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Baseline at ICU discharge. One, two and three month after ICU discharge
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Activities of daily living score, from baseline to one year after ICU discharge
Prazo: Baseline before hospital admission. ICU discharge, one, two, three,six month and one year after ICU discharge
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Measured by basic activities of daily living (ADL) in score, range from 0-100 score, higher score indicated health condition
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Baseline before hospital admission. ICU discharge, one, two, three,six month and one year after ICU discharge
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Instrumental activities of daily living score, from baseline to one year after ICU discharge
Prazo: Baseline at ICU discharge one month. Two, three, six month and one year after ICU discharge
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Measured by instrumental activities of daily living (IADL) in score, range from 0 to 8 score, higher score indicated better health condition
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Baseline at ICU discharge one month. Two, three, six month and one year after ICU discharge
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Scores of Medical Research Council (MRC) scale, from baseline to one year after ICU discharge
Prazo: Baseline at ICU discharge. One year after ICU discharge
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Measured by medical research council scale (MRC) in score, range from 0 to 60 score, higher score indicated better muscle strength
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Baseline at ICU discharge. One year after ICU discharge
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Self-report MRC questionnaire score
Prazo: At ICU discharge one month
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range from 0 to 60, score greater than or equal to 48, classified as no muscle weakness
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At ICU discharge one month
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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ICU, hospital and one-year mortality
Prazo: death (yes/no) at ICU, at hospital, and one year after ICU discharge obtained by family interview and medical record
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death (yes/no) at ICU, at hospital, and one year after ICU discharge obtained by family interview and medical record
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death (yes/no) at ICU, at hospital, and one year after ICU discharge obtained by family interview and medical record
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Length of ICU and hospital stay (day)
Prazo: calculated a duration of ICU and hospitalization, obtained by medical record
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calculated a duration of ICU and hospitalization, obtained by medical record
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calculated a duration of ICU and hospitalization, obtained by medical record
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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Time spent administering delirium tools
Prazo: time spent (minutes) administering ICDSC vs CAM-ICU was automatically recorded by the REDCap data collection system
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time spent (minutes) administering ICDSC vs CAM-ICU was automatically recorded by the REDCap data collection system
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time spent (minutes) administering ICDSC vs CAM-ICU was automatically recorded by the REDCap data collection system
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Cheryl Chia-Hui Chen Chen, PhD, School of Nursing, College of Medicine, National Taiwan University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 201802070RIND
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