Clinical trial NCT04206306: Functional Recovery Over the First Year After ICU Discharge
Official title: Functional Recovery Over the First Year After ICU Discharge：How ICU-delirium and ICU-acquired Weakness Interact
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adult Patients
Intensive Care Unit
Keywords: Intensive Care Unit Acquired Delirium
Intensive Care Unit Survivor
Intensive Care Unit Acquired Weakness
Functional recovery
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-12-20
Enrollment: 407
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive about patients (≧20 years) admitted to the six medical intensive care units at the National Taiwan University Hospital (NTUH).

Brief summary: Intensive Care Unit Acquired Delirium (ICU-AD) and Intensive Care Unit Acquired Weakness (ICU-AW) are common in critically ill, mechanically ventilated adult patients. As more patients survive ICU stays but suffer from long-term functional declines leading to unemployment and disability, research is urgently needed. The aims of this study are to: 1) describe the trajectory of physical functions one year after ICU discharge, including distance walked in 6 minutes (6MWD), hand grip (HGS), maximum inspiratory pressure (MIP), cognitive function (mini mental state examination,MMSE), physical function ICU test score (PFITs) , medical reserach council scale (MRC), medical research council questionnaire (MRC-Q)and basic and instrumental activities of daily living (ADL/IADL); 2) examine the incidences of ICU-AD and ICU-AW; and 3) test the interaction between ICU-AD and ICU-AW on one-year functional trajectories in the ICU survivors.4) compare two tools, the intensive care delirium screening checklist (ICDSC) and confusion assessment method for the ICU (CAM-ICU), for their predictive validity for outcomes related to delirium, hospital mortality and length of stay (LOS), and examined whether the tools' predictive validity was affected by patients' arousal status (RASS≥0, RASS\<0).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline 6-min walking distance to one year after ICU discharge
timeFrame: Baseline at ICU discharge one month. One,two, three,six month and one year after ICU discharge
measure: Change from baseline hand grip strength to one year after ICU discharge
timeFrame: Baseline at ICU discharge. One, two, three,six month and one year after ICU discharge
measure: Maximum inspiratory pressure, from baseline to one year after ICU discharge
timeFrame: Baseline at ICU discharge one month. Two, three, six month and one year after ICU discharge
measure: Change from baseline Mini-Mental State Examination to one year after ICU discharge
timeFrame: Baseline at ICU discharge. One, two, three, six month and one year after ICU discharge
measure: Physical function
timeFrame: Three months after ICU discharge
measure: Activities of daily living score, from baseline to one year after ICU discharge
timeFrame: Baseline before hospital admission. ICU discharge, one, two, three,six month and one year after ICU discharge
measure: Instrumental activities of daily living score, from baseline to one year after ICU discharge
timeFrame: Baseline at ICU discharge one month. Two, three, six month and one year after ICU discharge
measure: Scores of Medical Research Council (MRC) scale, from baseline to one year after ICU discharge
timeFrame: Baseline at ICU discharge. One year after ICU discharge
measure: Self-report MRC questionnaire score
timeFrame: At ICU discharge one month
measure: Sit-to-stand ability (yes/no)
timeFrame: Three months after ICU discharge
Secondary outcomes:
measure: ICU, hospital, and one-year mortality
timeFrame: death (yes/no) at ICU, at hospital, and one year after ICU discharge obtained by family interview and medical record
measure: Length of ICU and hospital stay (day)
timeFrame: calculated a duration of ICU and hospitalization, obtained by medical record
Other outcomes:
measure: Time spent administering delirium tools
timeFrame: time spent (minutes) administering ICDSC vs CAM-ICU was automatically recorded by the REDCap data collection system
measure: Diagnostic accuracy of HGS and MIP as surrogate markers for ICU-AW
timeFrame: Baseline at ICU discharge
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: School of Nursing, College of Medicine, National Taiwan University
name: Cheryl Chia-Hui Chen Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: