Outcome of Children Post Mechanical Ventilation
Functional and Respiratory Outcomes of Mechanically Ventilated Children in Pediatric Intensive Care, a Prospective Cohort Study
1 other identifier
observational
100
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2022
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2022
CompletedFirst Posted
Study publicly available on registry
February 8, 2022
CompletedStudy Start
First participant enrolled
December 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedFebruary 16, 2023
February 1, 2023
9 months
January 13, 2022
February 14, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Functional status
Functional Status Scale (FSS) Final scores range from 6 to 30 Higher scores mean a worse outcome.
12 months
Secondary Outcomes (5)
Respiratory status
12 months
Health related Quality of life
12 months
Psychosocial status of the child
12 months
Psychosocial status of the parents
12 months
Neurocognition
12 months
Eligibility Criteria
Children admitted to a PICU requiring mechanical ventilation for at least 48 hours.
You may qualify if:
- 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.
You may not qualify if:
- Patients admitted for congenital heart surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5, Canada
Hôpital de Montréal pour enfants (MCH)
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, Canada
Centre Hospitalier Universitaire de Québec - Université Laval (CHUL)
Québec, Canada
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Laurence Ducharme-Crevier, MD MSc
St. Justine's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Pediatric Intensivist
Study Record Dates
First Submitted
January 13, 2022
First Posted
February 8, 2022
Study Start
December 1, 2022
Primary Completion
September 1, 2023
Study Completion
September 1, 2024
Last Updated
February 16, 2023
Record last verified: 2023-02