Outcome of Children Post Mechanical Ventilation

Sponsor

St. Justine's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05227989

Collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre (Other), Centre de recherche du Centre hospitalier universitaire de Sherbrooke (Other), Laval University (Other)

100

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2023

Outcome Measures

Primary Outcome Measures

Functional status [12 months]
Functional Status Scale (FSS) Final scores range from 6 to 30 Higher scores mean a worse outcome.

Secondary Outcome Measures

Respiratory status [12 months]
6 minute walk test Result expressed in meters Higher score means better function
Health related Quality of life [12 months]
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
Psychosocial status of the child [12 months]
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.
Psychosocial status of the parents [12 months]
Hospital Anxiety & Depression Scale (HADS) (parents) Each category (Anxiety and Depression) range from 0 to 21) Higher scores mean a worse outcome.
Neurocognition [12 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital de Montréal pour enfants (MCH)	Montreal	Quebec	Canada
2	CHU Sainte-Justine	Montréal	Quebec	Canada	H3T 1C5
3	Centre Hospitalier Universitaire de Sherbrooke (CHUS)	Sherbrooke	Quebec	Canada
4	Centre Hospitalier Universitaire de Québec - Université Laval (CHUL)	Quebec		Canada

Sponsors and Collaborators

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

Investigators

Principal Investigator: Laurence Ducharme-Crevier, MD MSc, St. Justine's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Laurence Ducharme-Crevier, Principal Investigator, Pediatric Intensivist, St. Justine's Hospital

ClinicalTrials.gov Identifier:

NCT05227989

Other Study ID Numbers:

MP-21-2022-3571

First Posted:

Feb 8, 2022

Last Update Posted:

Feb 8, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 8, 2022