Functional Recovery in Critically Ill Children

Critical Illness Clinical Trial

Official title:

Functional Recovery in Critically Ill Children - the Wee-Cover Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01724593
• Other study ID #: HHS REB No. 12-475
• Status: Completed
• Phase: N/A
• First received: October 30, 2012
• Last updated: November 3, 2013
• Start date: October 2012
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months to 17 Years

Eligibility

Inclusion Criteria:

• Age over 12 months to 17 years

• PCCU stay of = 48 hours

• Patient is limited to bed-rest and has not been mobilized during the first 48 hours of PCCU admission

• Equal to or greater than one organ dysfunction on PCCU admission (as measured by PELOD)

• Informed consent of patient/substitute decision maker.

Exclusion Criteria:

• Age: < 12 months or =18 years

• Patients admitted to step-down/intermediate care

• Patients transferred from Neonatal intensive care unit and never discharge home.

iv) Patients who are already mobilizing well, or are at baseline functional status at time of screening v) Admission diagnosis of a neuromuscular disorder: e.g. Acute Guillain-Barré Syndrome, Botulism, Myasthenia Gravis), or acute spinal cord injury/transverse myelitis vi) Not expected to survive PCCU/hospital stay vii) Previously enrolled into study less than 6 months ago and/or still undergoing study procedures at time of screening

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Children
• Critical Illness

Locations

Country	Name	City	State
Canada	McMaster Children's Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Karen Choong

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility and reliability of screening for PCCU-acquired weakness	The most appropriate method of screening and diagnosing PCCU-acquired weakness has not been well established given the many challenges in ascertainment in this population. Hence, one of the objectives of this study is to determine whether manual muscle strength testing is a feasible and reliable method of screening for this important disorder in the critically ill pediatric population. Muscle strength will be quantified clinically using the (MRC) score by 2 independent assessors. For a subset of age appropriate (= 4 years), we will determine their hand-grip strength using a hand dynamometer or Martin Vigorimeter, depending on their age.	Duration of Hospitalization, 3 and 6 months follow-up	No
Primary	Feasibility	Feasibility will be determined by the consent and enrolment rate, and the protocol adherence and follow-up rates.	12 months	No
Secondary	Functional Recovery	Functional Recovery will be measured by the following standardized, validate pediatric assessment tools of function, as defined by the International Classification of Functioning, Disability and Health (ICF): 1) Pediatric Evaluation of Disability Inventory (PEDI); 2) Participation and Environment Measure - children and youth version (PEM-CY), and preschool version; 3) Pediatric Overall Performance Category score (POPC); 4) Pediatric Cerebral Performance Category Score (PCPC)	Baseline, 3 and 6 month follow-up	No
Secondary	Pediatric Critical care Unit (PCCU) clinical outcomes	PCCU outcomes will be assessed by the following: Ventilator-free days, PCCU mortality, length of PCCU and hospital stay, and the incidence of PCCU-acquired weakness	at 30 days and duration of hospitalization	No
Secondary	Muscle Strength	In an age-appropriate subgroup, the following measurements will be conducted: Muscle Strength and aerobic fitness testing (age = 5 years, and/or able to cognitively and physically comply with strength and fitness tests); Measurement of muscle strength using BIODEX and hand grip strength, and assessment of lean mass (Bioelectrical impedance analysis)	Hospital discharge and at 3 and 6 month follow-up	No
Secondary	Parental or caregiver stress	Parental or caregiver stress will be measured with the Parental Stress Index (PSI)	3 month follow-up	No