Ignite Creation Date:
2024-05-06 @ 2:04 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04206306
Status:
COMPLETED
Last Update Posted:
2023-02-02
First Post:
2018-08-08
Brief Title:
Functional Recovery Over the First Year After ICU Discharge
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Functional Recovery Over the First Year After ICU DischargeHow ICU-delirium and ICU-acquired Weakness Interact
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 examinationMMSE physical function ICU test score PFITs medical reserach council scale MRC medical research council questionnaire MRC-Qand basic and instrumental activities of daily living ADLIADL 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 survivors4 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 RASS0 RASS0
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 possibleif the the patients Richmond Agitation and Sedation Scale RASS -54 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 dischargeassess 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
At ICU dischargeassess 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None