Clinical trial NCT05227989: Outcome of Children Post Mechanical Ventilation
Official title: Functional and Respiratory Outcomes of Mechanically Ventilated Children in Pediatric Intensive Care, a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post Intensive Care Syndrome
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
Collaborators: name: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Laval University
First posted: 2022-02-08
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children admitted to a PICU requiring mechanical ventilation for at least 48 hours.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional status
timeFrame: 12 months
Secondary outcomes:
measure: Respiratory status
timeFrame: 12 months
measure: Health related Quality of life
timeFrame: 12 months
measure: Psychosocial status of the child
timeFrame: 12 months
measure: Psychosocial status of the parents
timeFrame: 12 months
measure: Neurocognition
timeFrame: 12 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Hôpital de Montréal pour enfants (MCH)
state: Quebec
city: Montréal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke (CHUS)
state: Quebec
city: Quebec
country: Canada
facility: Centre Hospitalier Universitaire de Québec - Université Laval (CHUL)
Study officials:
affiliation: St. Justine's Hospital
name: Laurence Ducharme-Crevier, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: