Outcome of Children Post Mechanical Ventilation

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

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.

Study Overview

• Status: Recruiting
• Conditions: Post Intensive Care Syndrome

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Laurence Ducharme-Crevier, MD MSc; Phone Number: 4118 514-345-4931; Email: lducharmecrevier@gmail.com

Study Locations

• Canada
  • Quebec, Canada
    • Not yet recruiting
    • Centre Hospitalier Universitaire de Québec - Université Laval (CHUL)
    • Contact: Conal Francoeur, MD MSc
  • Quebec
    • Montreal, Quebec, Canada
      • Recruiting
      • Hôpital de Montréal pour enfants (MCH)
      • Contact: Patricia Fontela, MD PhD
    • Montréal, Quebec, Canada, H3T 1C5
      • Recruiting
      • CHU Sainte-Justine
      • Contact: Laurence Ducharme-Crevier; Phone Number: 4118 514-345-4931; Email: lducharmecrevier@gmail.com
    • Sherbrooke, Quebec, Canada
      • Recruiting
      • Centre hospitalier universitaire de Sherbrooke (CHUS)
      • Contact: Jean-Sébastien Tremblay-Roy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children admitted to a PICU requiring mechanical ventilation for at least 48 hours.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: St. Justine's Hospital
• Collaborators: Centre de recherche du Centre hospitalier universitaire de Sherbrooke; McGill University Health Centre/Research Institute of the McGill University Health Centre; Laval University
• Investigators: Principal Investigator: Laurence Ducharme-Crevier, MD MSc, St. Justine's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: January 13, 2022
• First Submitted That Met QC Criteria: February 5, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Estimate): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MP-21-2022-3571

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No