Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-30 @ 2:06 PM
Study NCT ID:
NCT01724593
Status:
COMPLETED
Last Update Posted:
2013-11-05
First Post:
2012-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Recovery in Critically Ill Children
Sponsor:
Karen Choong
Organization:
Study Overview
Official Title:
Functional Recovery in Critically Ill Children - the Wee-Cover Pilot Study
Status:
COMPLETED
Status Verified Date:
2013-11
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 weakness (ICU-AW) is a well-recognized, important and preventable sequelae of critical illness, affecting up to 60% of adult ICU patient. ICU-AW is associated with increased mortality and length of stay, and negatively impacts long-term functional outcomes and quality of life in affected patients and their caregivers. While delayed mobilization adversely affects clinical outcomes, early rehabilitation in the critically ill adult population is safe, feasible, cost effective, results in more ventilator free-days and better functional outcomes at hospital discharge. In contrast, there is a paucity of this research in pediatrics. Our research suggests that immobilization is common in critically ill children, and rehabilitation is delayed particularly in the sickest children who are arguably at highest risk of morbidity. It is unclear however, whether delayed rehabilitation leads to adverse outcomes in critically ill children, as has been demonstrated in adults. Our objectives of this study are to evaluate if immobilization and delayed rehabilitation negatively impacts short-term clinical outcomes and the time to functional recovery in critically ill children. The investigators hypothesize that the following factors may influence functional recovery and morbidity in critically ill children:
* Pre-morbid condition
* Age
* Time-to-initiation of acute rehabilitation
* Critical illness disease severity
* Pre-morbid condition
* Age
* Time-to-initiation of acute rehabilitation
* Critical illness disease severity
Detailed Description:
Overall Study objectives:
1. To describe the functional recovery following prolonged immobility and delayed rehabilitation in critically ill children.
2. To explore the predictors of impaired functional recovery following immobilization in critically ill children.
Prior to conducting a definitive multi-centre study to answer our research questions and achieve our study objectives above, we will conduct a pilot study in order to demonstrate feasibility.
1. To describe the functional recovery following prolonged immobility and delayed rehabilitation in critically ill children.
2. To explore the predictors of impaired functional recovery following immobilization in critically ill children.
Prior to conducting a definitive multi-centre study to answer our research questions and achieve our study objectives above, we will conduct a pilot study in order to demonstrate feasibility.
Study Oversight
Has Oversight DMC:
False
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?: