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Clinical Trials/NCT05227989
NCT05227989
Recruiting
N/A

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

St. Justine's Hospital4 sites in 1 country100 target enrollmentDecember 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Post Intensive Care Syndrome
Sponsor
St. Justine's Hospital
Enrollment
100
Locations
4
Primary Endpoint
Functional status
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2022
End Date
September 1, 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
St. Justine's Hospital
Responsible Party
Principal Investigator
Principal Investigator

Laurence Ducharme-Crevier

Principal Investigator, Pediatric Intensivist

St. Justine's Hospital

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

Outcomes

Primary Outcomes

Functional status

Time Frame: 12 months

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

Secondary Outcomes

  • Respiratory status(12 months)
  • Health related Quality of life(12 months)
  • Neurocognition(12 months)
  • Psychosocial status of the child(12 months)
  • Psychosocial status of the parents(12 months)

Study Sites (4)

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