Adult PatientsNCT04206306
Functional Recovery Over the First Year After ICU Discharge
An observational study of Adult Patients and Intensive Care Unit, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Adult Patients, Intensive Care Unit
- How many people
- 407 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Aug 2018to 12 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive about patients (≧20 years) admitted to the six medical intensive care units at the National Taiwan University Hospital (NTUH).
Who may be able to join
- Patient who is 20 years or older.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Recovery Over the First Year After ICU Discharge：How ICU-delirium and ICU-acquired Weakness Interact
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).
Read the 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.
- Conditions
- Adult Patients, Intensive Care Unit
- Keywords
- Intensive Care Unit Acquired Delirium, Intensive Care Unit Survivor, Intensive Care Unit Acquired Weakness, Functional recovery
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline 6-min walking distance to one year after ICU discharge
Measured by distance walked in 6 minutes(6MWT) in meter
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: calculated a duration of ICU and hospitalization, obtained by medical record
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start14 Aug 2018
- Primary completion26 Nov 2020
- Study completion12 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adult PatientsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheryl Chia-Hui Chen Chen, PhD, Principal investigator, School of Nursing, College of Medicine, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206306
- Sponsor's protocol ID
- 201802070RIND
- Status last verified
- Jul 2021
- First submitted
- 8 Aug 2018
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Siao SF, Ku SC, Hsu AS, Wei YC, Li HC, Yeh TY, Boehm LM, Chen CC. ICU Delirium Patterns and 30-Day Mortality in Critically Ill Adults. Nurs Crit Care. 2026 May;31(3):e70514. doi: 10.1111/nicc.70514.
PubMed 42132087Siao 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.
PubMed 39468861
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Recovery Over the First Year After ICU Discharge：How ICU-delirium and ICU-acquired Weakness Interact
- ClinicalTrials.gov ID
- NCT04206306
- Acronym / sponsor ID
- 201802070RIND
- Conditions
- Adult Patients, Intensive Care Unit
- Keywords
- Intensive Care Unit Acquired Delirium, Intensive Care Unit Survivor, Intensive Care Unit Acquired Weakness, Functional recovery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- 26 Nov 2020 (actual)
- Study completion
- 12 Jul 2021 (actual)
- First posted
- 20 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive about patients (≧20 years) admitted to the six medical intensive care units at the National Taiwan University Hospital (NTUH).
Key inclusion criteria (1 listed)
- Patient who is 20 years or older.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
Physical function
Time frame: Three months after ICU discharge
Measured by Physical function ICU test score (PFITs)
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
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
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
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
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.
2 secondary outcomes
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
Length of ICU and hospital stay (day)
Time frame: calculated a duration of ICU and hospitalization, obtained by medical record
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Derived from this study: PubMed 42132087Siao SF, Ku SC, Hsu AS, Wei YC, Li HC, Yeh TY, Boehm LM, Chen CC. ICU Delirium Patterns and 30-Day Mortality in Critically Ill Adults. Nurs Crit Care. 2026 May;31(3):e70514. doi: 10.1111/nicc.70514.
- Derived from this study: PubMed 39468861Siao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheryl Chia-Hui Chen Chen, PhD principal investigator
School of Nursing, College of Medicine, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult Patients and Intensive Care Unit, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04206306, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.