Outcome of Children Post Mechanical Ventilation

Post Intensive Care Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05227989
• Other study ID #: MP-21-2022-3571
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: February 2023
• Source: St. Justine's Hospital
• Contact: Laurence Ducharme-Crevier, MD MSc
• Phone: 514-345-4931
• Email: lducharmecrevier[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Post Intensive Care Syndrome

Locations

Country	Name	City	State
Canada	Hôpital de Montréal pour enfants (MCH)	Montreal	Quebec
Canada	CHU Sainte-Justine	Montréal	Quebec
Canada	Centre Hospitalier Universitaire de Québec - Université Laval (CHUL)	Quebec
Canada	Centre Hospitalier Universitaire de Sherbrooke (CHUS)	Sherbrooke	Quebec

Sponsors (4)

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

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional status	Functional Status Scale (FSS) Final scores range from 6 to 30 Higher scores mean a worse outcome.	12 months
Secondary	Respiratory status	6 minute walk test Result expressed in meters Higher score means better function	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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