Functional Recovery Over the First Year After ICU Discharge

Intensive Care Unit Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04206306
• Other study ID #: 201802070RIND
• Status: Completed
• Start date: August 14, 2018
• Est. completion date: July 12, 2021

Study information

• Verified date: July 2021
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 407
• Est. completion date: July 12, 2021
• Est. primary completion date: November 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adult Patients
• Intensive Care Unit

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time spent administering delirium tools	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Physical function	Measured by Physical function ICU test score (PFITs)	Three months after ICU discharge
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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	death (yes/no) at ICU, at hospital, and one year after ICU discharge obtained by family interview and medical record
Secondary	Length of ICU and hospital stay (day)	calculated a duration of ICU and hospitalization, obtained by medical record	calculated a duration of ICU and hospitalization, obtained by medical record