Post-discharge Outcomes of Pediatric Acute Respiratory Distress Syndrome
- Conditions
- Pediatric Acute Respiratory Distress Syndrome
- Interventions
- Other: Prospective follow-up
- Registration Number
- NCT03585582
- Lead Sponsor
- St. Justine's Hospital
- 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 Previous studies were limited by their sample size, were outdated in PARDS management strategies, and used the adult ARDS diagnostic criteria.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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 77
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PARDS survivors Prospective follow-up 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
- Primary Outcome Measures
Name Time Method Prevalence of respiratory symptoms At 1 year following the discharge Prevalence of respiratory symptoms (cough, exercise intolerance, wheezing, etc.)
- Secondary Outcome Measures
Name Time Method Cardiopulmonary exercise testing - CO2 output At 1 year following the discharge CO2 output measured using a standardized maximal incremental cycle ergometry protocol in children ≥ 8 years.
Cardiopulmonary exercise testing - respiratory exchange ratio At 1 year following the discharge Respiratory exchange ratio measured using a standardized maximal incremental cycle ergometry protocol in children ≥ 8 years.
Cardiopulmonary exercise testing - anaerobic threshold At 1 year following the discharge Anaerobic threshold measured using a standardized maximal incremental cycle ergometry protocol in children ≥ 8 years.
Pulmonary function - Forced expiratory volume in 1 second At 1 year following the discharge Forced expiratory volume in 1 second (FEV1) in L and z-score based on references from the Global Lung Initiative.
Pulmonary function - lung volumes At 1 year following the discharge Lung volumes (total lung capacity, functional residual capacity, residual volumes) in L. Outcome measured in patients 8 years and above only.
Pulmonary function - diffusion capacity At 1 year following the discharge Diffusion capacity of CO (DLCO). Outcome measured in patients 8 years and above only.
Pulmonary function - maximal inspiratory and expiratory pressures At 1 year following the discharge Maximal inspiratory and expiratory pressures in cm H2O. Outcome measured in patients 6 years and above only.
Pulmonary function - resistance at 5Hz At 1 year following the discharge Respiratory resistance measured using oscillometry at 5 Hz. Outcome measured in patients 3-5 years old and those who cannot perform spirometry.
Cardiopulmonary exercise testing - VO2max At 1 year following the discharge VO2max measured using a standardized maximal incremental cycle ergometry protocol in children ≥ 8 years.
non-respiratory PELOD-2 score At 7 days PELOD-2 score - validated score predictive of mortality (quantifies the severity of organ dysfunction). There are 7 items describing 4 organ dysfunction (respiratory component is removed). The score ranges from 0 to 25, with higher score indicating more organ dysfunction.
Pulmonary function - FEV1/FVC At 1 year following the discharge FEV1/FVC ratio z-score based on references from the Global Lung Initiative
Pulmonary function - Forced vital capacity (FVC) At 1 year following the discharge Forced vital capacity (FVC) in L and z-score based on references from the Global Lung Initiative.
Health-related quality of life - Infant Toddler Quality of Life Questionnaire At 1 year following the discharge Health-related quality of life using the Infant Toddler Quality of Life Questionnaire (ages 2 months to 2 years). There are 8 scales to this 47-item questionnaire: overall health, physical abilities, growth and development, bodily pain/discomfort, temperament and mood, combined behavior, general health perceptions, change in health. There are also 3 scales that assess the impact on the parent: parental impact-emotional, parental impact-time, family cohesion. Transformed scores for all scales range from 0 to 100, with a higher score indicating better health.
Health-related quality of life - Pediatric Quality of Life Inventory At 1 year following the discharge Health-related quality of life using the Pediatric Quality of Life Inventory (≥2 years), Generic core scale. There are separate versions for 2-4 year-olds (parent report only), 5-7 (parent and child report), 8-12 (parent and child report), 13-18 (parent and child report). Scores are transformed on a scale from 0 to 100, with a higher score indicating better health-related quality of life.
Mental health - Child Behavior Checklist At 1 year following the discharge Mental health assessed by the parent-completed Child Behavior Checklist (age ≥ 18 months). The 6 scales are based on the DSM5: depressive problems, anxiety problems, somatic problems, attention deficit/hyperactivity problems, oppositional defiant problems, conduct problems. The raw scores are transformed into percentiles for each scale. The higher the percentile, the more problems there are.
Post-traumatic stress syndrome - Children's Impact of Event Scales At 1 year following the discharge Post-traumatic stress syndrome symptoms using the Children's Impact of Event Scales (≥ 7 years). There are 8 items that are scored on a four point scale (total score from 0 to 40). A total score of 17 or more indicates symptoms suggestive of PTSD.
Post-traumatic stress syndrome - parents PTSD Checklist At 1 year following the discharge Post-traumatic stress syndrome symptoms in the parents using the parents PTSD Checklist. There are 20 items that are scored from 0-4 each (total score from 0 to 80). A PCL-5 score of 33 or more indicates symptoms suggestive of PTSD.
Health resources use At 1 year following the discharge Health resources use, including all-cause emergency department visits or re-hospitalizations.
Trial Locations
- Locations (1)
Sainte-Justine University Hospital Centre
🇨🇦Montréal, Quebec, Canada