Skip to main content
OpenTrials
Completed

NCT Number: NCT04206306

Functional Recovery Over the First Year After ICU Discharge

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adult Patients Intensive Care Unit

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, 10055, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Change from baseline 6-min walking distance to one year after ICU discharge

    Time frame: Baseline at ICU discharge one month. One,two, three,six month and one year after ICU discharge

    Measured by distance walked in 6 minutes(6MWT) in meter

  2. Change from baseline hand grip strength to one year after ICU discharge

    Time frame: Baseline at ICU discharge. One, two, three,six month and one year after ICU discharge

    Measured by hand grip strength (HGS) in kg, range from 20 to 65 kg, higher value indicated better musculoskeletal function

  3. Maximum inspiratory pressure, from baseline to one year after ICU discharge

    Time frame: Baseline at ICU discharge one month. Two, three, six month and one year after ICU discharge

    Measured by maximum inspiratory pressure (MIP test ) in cmH2O, normal range < -20 cmH2O, lower value indicated better respiratory muscle condition

  4. Change from baseline Mini-Mental State Examination to one year after ICU discharge

    Time frame: Baseline at ICU discharge. One, two, three, six month and one year after ICU discharge

    Measured by Mini-Mental State Examination (MMSE) in score, range from 0 to 30 score, higher score indicated better cognitive function

  5. Physical function

    Time frame: Three months after ICU discharge

    Measured by Physical function ICU test score (PFITs)

  6. Activities of daily living score, from baseline to one year after ICU discharge

    Time frame: Baseline before hospital admission. ICU discharge, one, two, three,six month and one year after ICU discharge

    Measured by basic activities of daily living (ADL) in score, range from 0-100 score, higher score indicated health condition

  7. Instrumental activities of daily living score, from baseline to one year after ICU discharge

    Time frame: Baseline at ICU discharge one month. Two, three, six month and one year after ICU discharge

    Measured by instrumental activities of daily living (IADL) in score, range from 0 to 8 score, higher score indicated better health condition

  8. Scores of Medical Research Council (MRC) scale, from baseline to one year after ICU discharge

    Time frame: Baseline at ICU discharge. One year after ICU discharge

    Measured by medical research council scale (MRC) in score, range from 0 to 60 score, higher score indicated better muscle strength

  9. Self-report MRC questionnaire score

    Time frame: At ICU discharge one month

    range from 0 to 60, score greater than or equal to 48, classified as no muscle weakness

  10. Sit-to-stand ability (yes/no)

    Time frame: Three months after ICU discharge

    Asking participants to rise from a seated position, with full body weight on the chair, to a standing posture, with their legs fully extended.

Secondary outcomes

  1. ICU, hospital, and one-year mortality

    Time frame: death (yes/no) at ICU, at hospital, and one year after ICU discharge obtained by family interview and medical record

    death (yes/no) at ICU, at hospital, and one year after ICU discharge obtained by family interview and medical record

  2. Length of ICU and hospital stay (day)

    Time frame: calculated a duration of ICU and hospitalization, obtained by medical record

    calculated a duration of ICU and hospitalization, obtained by medical record

Other outcomes

  1. Time spent administering delirium tools

    Time frame: time spent (minutes) administering ICDSC vs CAM-ICU was automatically recorded by the REDCap data collection system

    time spent (minutes) administering ICDSC vs CAM-ICU was automatically recorded by the REDCap data collection system

  2. Diagnostic accuracy of HGS and MIP as surrogate markers for ICU-AW

    Time frame: Baseline at ICU discharge

    Measured by the area under the ROC curve (AUC), sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Functional Recovery Over the First Year After ICU Discharge：How ICU-delirium and ICU-acquired Weakness Interact

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Dec 20, 2019
Registry last updated
Jan 20, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.