NCT05227989

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

February 16, 2023

Status Verified

February 1, 2023

Enrollment Period

9 months

First QC Date

January 13, 2022

Last Update Submit

February 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Functional status

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

    12 months

Secondary Outcomes (5)

  • Respiratory status

    12 months

  • Health related Quality of life

    12 months

  • Psychosocial status of the child

    12 months

  • Psychosocial status of the parents

    12 months

  • Neurocognition

    12 months

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Patients admitted for congenital heart surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

RECRUITING

Hôpital de Montréal pour enfants (MCH)

Montreal, Quebec, Canada

RECRUITING

Centre Hospitalier Universitaire de Sherbrooke (CHUS)

Sherbrooke, Quebec, Canada

RECRUITING

Centre Hospitalier Universitaire de Québec - Université Laval (CHUL)

Québec, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

postintensive care syndrome

Study Officials

  • Laurence Ducharme-Crevier, MD MSc

    St. Justine's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurence Ducharme-Crevier, MD MSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Pediatric Intensivist

Study Record Dates

First Submitted

January 13, 2022

First Posted

February 8, 2022

Study Start

December 1, 2022

Primary Completion

September 1, 2023

Study Completion

September 1, 2024

Last Updated

February 16, 2023

Record last verified: 2023-02

Locations