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Outcome of Children Post Mechanical Ventilation

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05227989
Enrollment
100
Registered
2022-02-08
Start date
2022-12-01
Completion date
2024-09-01
Last updated
2023-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Intensive Care Syndrome

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.

Detailed description

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.

Interventions

None listed

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre
CollaboratorOTHER
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
CollaboratorOTHER
Laval University
CollaboratorOTHER
St. Justine's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Functional status12 monthsFunctional Status Scale (FSS) Final scores range from 6 to 30 Higher scores mean a worse outcome.

Secondary

MeasureTime frameDescription
Respiratory status12 months6 minute walk test Result expressed in meters Higher score means better function
Health related Quality of life12 monthsPedsQL™ 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
Psychosocial status of the child12 monthsChild 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.
Psychosocial status of the parents12 monthsHospital Anxiety & Depression Scale (HADS) (parents) Each category (Anxiety and Depression) range from 0 to 21) Higher scores mean a worse outcome.
Neurocognition12 monthsTest 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

Countries

Canada

Contacts

Primary ContactLaurence Ducharme-Crevier, MD MSc
lducharmecrevier@gmail.com514-345-4931

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026