Outcome of Children Post Mechanical Ventilation

Study Overview
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Brief Summary
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Mechanical ventilation is a life-saving therapy widely used in PICU, but not without adverse effects. The mid-term outcome of mechanically ventilated children who survive critical illness is still poorly defined, in terms of respiratory status, functionality, and quality of life. This lack of knowledge can lead to delays in management and thus hinder the recovery of children. The aim of this study is to determine the impact on the functional and respiratory outcome of pediatric patients after a stay a PICU of the province of Quebec.

Detailed Description
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This is a prospective longitudinal cohort study of pediatric patients requiring mechanical ventilation for at least 48 hours, in all 4 PICUs in the province of Quebec (Canada). In follow-up PICU clinics, children and family outcomes will be evaluated 2, 6 and 12 months post PICU discharge.Children and their families will be enrolled locally from each PICU, their baseline data will be collected by local research staff and their post-discharge outcomes will be followed centrally from the Centre Hospitalier Universitaire Sainte-Justine. The specific aims are to determine the functional, respiratory and neurocognitive function of PICU survivors and Health related Quality of life. Psychosocial status of the child and parents will also be determined. The primary goal is to describe the impact of a critical illness and mechanical ventilation on PICU survivors and their families in order to improve the health and well-being of PICU survivors and their families, and ultimately to improve the care of children after a PICU stay.

Official Title
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Functional and Respiratory Outcomes of Mechanically Ventilated Children in Pediatric Intensive Care, a Prospective Cohort Study

Conditions
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Post Intensive Care Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients < 18 years of age; Admission to a PICU at the Centre Hospitalier Universitaire Sainte-Justine (CHUSJ), Montreal Children's Hospital (MCH), Centre Hospitalier Universitaire de Québec - Université Laval (CHUL) or Centre Hospitalier Universitaire de Sherbrooke (CHUS); Patients with invasive mechanical ventilation for ≥48 hours. Exclusion Criteria: Patients admitted for congenital heart surgery

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional status | Functional Status Scale (FSS) Final scores range from 6 to 30 Higher scores mean a worse outcome. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory status | 6 minute walk test Result expressed in meters Higher score means better function | 12 months | 
| Health related Quality of life | PedsQL™ 4.0 Generic Core or Infant Scales (self report or report parent) Final scores range from 0 to 100 Higher scores mean a better outcome | 12 months | 
| Psychosocial status of the child | Child PTSD Symptom Scale for DSM-5 (CPSS-5) (children 1year+) The total severity score ranges from 0 to 80 Higher scores mean a worse outcome. | 12 months | 
| Psychosocial status of the parents | Hospital Anxiety & Depression Scale (HADS) (parents) Each category (Anxiety and Depression) range from 0 to 21) Higher scores mean a worse outcome. | 12 months | 
| Neurocognition | Test according to age of patient: Bayley Scales of Infant Development III (1-30months) Wechsler Preschool and Primary Scale of Intelligence IV (WPPSI) (30months-7year) Wechsler Intelligence Scale for Children V (WISC)(7-16year) Wechsler Adult Intelligence Scale IV (WAIS)(16year+) These tests provide standardized norms, percentiles and age equivalent percentiles. The mean score is 100 ± SD15. Higher score mean better functioning | 12 months |