Outcome of Children Post Mechanical Ventilation | NCT05227989

Studies
Outcome of Children Post Mechanical Ventilation

NCT05227989

Sponsor

St. Justine's Hospital

Status

Unknown status

Last Update Posted

Feb 16, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Post Intensive Care Syndrome

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2022Actual

Primary Completion Date

Sep 1, 2023Estimated

Completion Date

Sep 1, 2024Estimated

First Submitted Date

Jan 13, 2022

First Submission Date that Met QC Criteria

Feb 5, 2022

First Posted Date

Feb 8, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2023

Last Update Posted Date

Feb 16, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

St. Justine's HospitalOTHER

Collaborators

Name	Class
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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Functional status	Functional Status Scale (FSS) Final scores range from 6 to 30 Higher scores mean a worse outcome.	12 months

Secondary Outcomes

Measure	Description	Time Frame
Respiratory status	6 minute walk test Result expressed in meters Higher score means better function	12 months
Health related Quality of life	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Laurence Ducharme-Crevier, MD MSc	Contact	514-345-4931	4118	lducharmecrevier@gmail.com

Overall Officials

Name	Affiliation	Role
Laurence Ducharme-Crevier, MD MSc	St. Justine's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Sainte-Justine	Recruiting	Montreal	Quebec	H3T 1C5	Canada

Condition Browse Module

MeSH Terms

ID	Term
C000657744	postintensive care syndrome

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided