Functional Recovery Over the First Year After ICU Discharge

NCT04206306 | Completed

• 1 other identifier: 201802070RIND
• Study Type: observational
• Target: 407
• Locations: 1 country
• Sites: 1

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).

Conditions

Adult Patients; Intensive Care Unit

Keywords

Intensive Care Unit Acquired Delirium; Intensive Care Unit Survivor; Intensive Care Unit Acquired Weakness; Functional recovery

Outcome Measures

Primary Outcomes (10)

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

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

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

• Change from baseline hand grip strength to 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

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

• Maximum inspiratory pressure, from baseline to 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

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

• Change from baseline Mini-Mental State Examination to 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

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

• Physical function

  Measured by Physical function ICU test score (PFITs)

  Three months after ICU discharge

• Activities of daily living score, from baseline to 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

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

• Instrumental activities of daily living score, from baseline to 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

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

• Scores of Medical Research Council (MRC) scale, from baseline to 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

  Baseline at ICU discharge. One year after ICU discharge

• Self-report MRC questionnaire score

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

  At ICU discharge one month

• Sit-to-stand ability (yes/no)

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

  Three months after ICU discharge

Secondary Outcomes (2)

• ICU, hospital, and one-year mortality

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

• Length of ICU and hospital stay (day)

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

Other Outcomes (2)

• Time spent administering delirium tools

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

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

  Baseline at ICU discharge

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Patient who is 20 years or older.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 10055, Taiwan

Location

Related Publications (1)

• Siao SF, Zheng YY, Wei YC, Boehm LM, Chen CC. Delirium and Weakness Acquired in the Intensive Care Unit: Individual and Combined Effects on 90-Day Mortality in Survivors of Critical Illness. J Clin Nurs. 2025 Sep;34(9):3620-3627. doi: 10.1111/jocn.17517. Epub 2024 Oct 29.

  PMID: 39468861 DERIVED

Study Officials

• Cheryl Chia-Hui Chen Chen, PhD

  School of Nursing, College of Medicine, National Taiwan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: December 20, 2019
• Study Start: August 14, 2018
• Primary Completion: November 26, 2020
• Study Completion: July 12, 2021
• Last Updated: January 20, 2025

Record last verified: 2021-07

Locations

TW (1)