Pediatric Acute Respiratory Distress Syndrome: Determining Post-discharge Outcomes, the Effect of Early Diagnosis, and Identifying Inflammatory Signatures to Better Understand Disease Mechanism
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pediatric Acute Respiratory Distress Syndrome
- Sponsor
- St. Justine's Hospital
- Enrollment
- 77
- Locations
- 1
- Primary Endpoint
- Prevalence of respiratory symptoms
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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 Previous studies were limited by their sample size, were outdated in PARDS management strategies, and used the adult ARDS diagnostic criteria.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.
Investigators
Sze Man Tse
Pediatric Respirologist, Assistant Clinical Professor
St. Justine's Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Prevalence of respiratory symptoms
Time Frame: At 1 year following the discharge
Prevalence of respiratory symptoms (cough, exercise intolerance, wheezing, etc.)
Secondary Outcomes
- Pulmonary function - Forced expiratory volume in 1 second(At 1 year following the discharge)
- Pulmonary function - lung volumes(At 1 year following the discharge)
- Cardiopulmonary exercise testing - CO2 output(At 1 year following the discharge)
- Cardiopulmonary exercise testing - respiratory exchange ratio(At 1 year following the discharge)
- Cardiopulmonary exercise testing - anaerobic threshold(At 1 year following the discharge)
- Pulmonary function - diffusion capacity(At 1 year following the discharge)
- Pulmonary function - maximal inspiratory and expiratory pressures(At 1 year following the discharge)
- Pulmonary function - resistance at 5Hz(At 1 year following the discharge)
- Cardiopulmonary exercise testing - VO2max(At 1 year following the discharge)
- non-respiratory PELOD-2 score(At 7 days)
- Pulmonary function - FEV1/FVC(At 1 year following the discharge)
- Pulmonary function - Forced vital capacity (FVC)(At 1 year following the discharge)
- Health-related quality of life - Infant Toddler Quality of Life Questionnaire(At 1 year following the discharge)
- Health-related quality of life - Pediatric Quality of Life Inventory(At 1 year following the discharge)
- Mental health - Child Behavior Checklist(At 1 year following the discharge)
- Post-traumatic stress syndrome - Children's Impact of Event Scales(At 1 year following the discharge)
- Post-traumatic stress syndrome - parents PTSD Checklist(At 1 year following the discharge)
- Health resources use(At 1 year following the discharge)