Post-discharge Outcomes of Pediatric Acute Respiratory Distress Syndrome

NCT ID: NCT03585582

Last Updated: 2022-10-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 77 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-31
• Study Completion Date: 2023-08-01

Brief Summary

In this study, the investigators aim to better characterize the outcomes of pediatric acute respiratory distress syndrome (PARDS) survivors, to examine whether subgroups of children with PARDS can be identified, and to determine whether an earlier diagnosis of PARDS using a computerized decision support system will improve the care of these children.

Detailed Description

Pediatric acute respiratory distress syndrome (PARDS), a heterogeneous clinical syndrome characterized by acute lung injury and hypoxemia, affects up to 10% of pediatric intensive care unit (ICU) patients and has a mortality rate of 18-27%. Because children who survived PARDS are still developing, long-term morbidities are highly relevant, although data on the outcomes of PARDS survivors is lacking. Previous studies were limited by their sample size, were outdated in PARDS management strategies, and used the adult ARDS diagnostic criteria. Some studies focused on pulmonary function but not on other patient-oriented outcomes such as respiratory symptoms, mental health issues, quality of life, and health care resource use, all of which have been identified as prevalent issues in adult ARDS survivors. Recently, adult studies have identified 2 distinct ARDS subphenotypes with differential responses to treatment using clinical and limited biological data, providing insight on the pathophysiology of ARDS. Whether these phenotypes are present in PARDS is unknown. Furthermore, integrating newer technologies such as transcriptomics in the identification of subphenotypes may improve our understanding of disease mechanisms. Finally, delays in ARDS diagnosis are common and compliance with current ARDS ventilation management guidelines is poor, ranging from 20-39% even in patients selected for clinical trials. Thus, novel methods such as decision support systems may play a role in the diagnosis and management of PARDS patients, although this remains to be evaluated.

Conditions

Pediatric Acute Respiratory Distress Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PARDS survivors

1. Children <18 years

2. diagnosed with PARDS, as defined by PALICC

3. admitted to the ICU at the CHUSJ, a pediatric tertiary care center

Prospective follow-up

Intervention Type: OTHER

This is a prospective follow-up study to assess of outcomes at 1 year following the discharge from the hospitalization during which PARDS was diagnosed

Interventions

Prospective follow-up

This is a prospective follow-up study to assess of outcomes at 1 year following the discharge from the hospitalization during which PARDS was diagnosed

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• clinical diagnosis of PARDS, as defined by PALICC
• aged less than 18 years
• admitted to the intensive care unit

Exclusion Criteria

• none

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

St. Justine's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sze Man Tse

Pediatric Respirologist, Assistant Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sze Man Tse, MD

Role: PRINCIPAL_INVESTIGATOR

St. Justine's Hospital

Locations

Sainte-Justine University Hospital Centre

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Sze Man Tse, MD

Role: CONTACT

sze.man.tse@umontreal.ca

514-345-4931 ext. 5409

Vincent Lague

Role: CONTACT

vincent.lague.hsj@ssss.gouv.qc.ca

514-345-4931

Facility Contacts

Sze Man Tse, MD

Role: primary

sze.man.tse@umontreal.ca

514-345-4931 ext. 5409

Vincent Lague

Role: backup

vincent.lague.hsj@ssss.gouv.qc.ca

514-345-4931

Other Identifiers

MRC-155352

Identifier Type: -

Identifier Source: org_study_id