Outcome of Children Post Mechanical Ventilation

NCT ID: NCT05227989

Last Updated: 2023-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-09-01

Brief Summary

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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

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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.

Conditions

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Post Intensive Care Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role collaborator

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

OTHER

Sponsor Role collaborator

Laval University

OTHER

Sponsor Role collaborator

St. Justine's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Laurence Ducharme-Crevier

Principal Investigator, Pediatric Intensivist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laurence Ducharme-Crevier, MD MSc

Role: PRINCIPAL_INVESTIGATOR

St. Justine's Hospital

Locations

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CHU Sainte-Justine

Montreal, Quebec, Canada

Site Status RECRUITING

Hôpital de Montréal pour enfants (MCH)

Montreal, Quebec, Canada

Site Status RECRUITING

Centre Hospitalier Universitaire de Sherbrooke (CHUS)

Sherbrooke, Quebec, Canada

Site Status RECRUITING

Centre Hospitalier Universitaire de Québec - Université Laval (CHUL)

Québec, , Canada

Site Status NOT_YET_RECRUITING

Countries

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Canada

Central Contacts

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Laurence Ducharme-Crevier, MD MSc

Role: CONTACT

514-345-4931 ext. 4118

Facility Contacts

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Laurence Ducharme-Crevier

Role: primary

514-345-4931 ext. 4118

Patricia Fontela, MD PhD

Role: primary

Jean-Sébastien Tremblay-Roy, MD

Role: primary

Conal Francoeur, MD MSc

Role: primary

Other Identifiers

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MP-21-2022-3571

Identifier Type: -

Identifier Source: org_study_id

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