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Long Term Follow up of Children Enrolled in the REDvent Study
Sponsor: Children's Hospital Los Angeles
Summary
This is a prospective observational follow-up study of children enrolled in a single center randomized controlled trial (REDvent). Nearly 50% of adult Acute Respiratory Distress Syndrome (ARDS) survivors are left with significant abnormalities in pulmonary, physical, neurocognitive function and Health Related Quality of Life (HRQL) which may persist for years.Data in pediatric ARDS (PARDS) survivors is limited. More importantly, there are no data identifying potentially modifiable factors during ICU care which are associated with long term impairments, which may include medication choices, or complications from mechanical ventilator (MV) management in the ICU including ventilator induced lung injury (VILI) or ventilator induced diaphragm dysfunction (VIDD). The Real-time effort driven ventilator (REDvent) trial is testing a ventialtor management algorithm which may prevent VIDD and VILI. VIDD and VILI have strong biologic plausibility to affect the post-ICU health of children with likely sustained effects on lung repair and muscle strength. Moreover, common medication choices (i.e. neuromuscular blockade, corticosteroids) or other complications in the ICU (i.e. delirium) are likely to have independent effects on the long term health of these children. This proposed study will obtain serial follow-up of subjects enrolled in REDvent (intervention and control patients). The central hypothesis is that preventing VIDD, VILI and shortening time on MV will have a measureable impact on longer term function by mitigating abnormalities in pulmonary function (PFTs), neurocognitive function and emotional health, functional status and HRQL after hospital discharge for children with PARDS. For all domains, the investigators will determine the frequency, severity and trajectory of recovery of abnormalities amongst PARDS survivors after ICU discharge, identify risk factors for their development, and determine if they are prevented by REDvent. They will leverage the detailed and study specific respiratory physiology data being obtained in REDvent, and use a variety of multi-variable models for comprehensive analysis. Completion of this study will enable the investigators to identify ICU related therapies associated with poor long term outcome, and determine whether they can be mitigated by REDvent.
Official title: The Effect of Intensive Care Unit Therapies and Mechanical Ventilation Strategy on Long Term Outcome in Pediatric ARDS A Follow-up of the Real-time Effort Driven VENTilator Management Study (REDvent)
Key Details
Gender
All
Age Range
1 Month - 18 Years
Study Type
OBSERVATIONAL
Enrollment
176
Start Date
2018-10-01
Completion Date
2026-05-01
Last Updated
2025-04-17
Healthy Volunteers
No
Conditions
Interventions
Ventilation Inhomogeneity
Ventilation inhomogeneity will be measured using the Lung Clearance Index (LCI), derived from multiple breath Nitrogen washout during tidal breathing, measured by a mouthpiece or mask covering nose and mouth.
Diaphragm Ultrasound
Diaphragm thickness and contractile activity measured during tidal breathing.
Respiratory Inductance Plethysmography
Measure of thoraco-abdominal asynchrony during tidal breathing
Spirometry
Measurement of Forced Expiratory Volume (FEV1), Forced Vital Capacity and other lung volumes using standard pulmonary function techniques
Functional Residual Capacity
Measurement using body box plethysmography of functional residual capacity and other lung volumes using standard pulmonary function techniques
MIP/MEP
Measurement of maximal inspiratory and expiratory pressures during airway occlusion
6 minute walk test
Measurement of cardio-respiratory function and capabilities during treadmill walking for 6 minutes.
Neurocognitive Testing
Detailed in person neuro-cognitive testing using standardized inventories using either the Battelle Developmental Inventory, second edition (Battelle-2) (age birth to 5 years 11 months) and the Wechsler Intelligence Scale for Children, fifth edition (WISC-5, for age 6 years to 19 years).
Emotional Health Assessment
In person and written assessments of children and parents using the Behavioral Assessment System for Children, third edition (BASC-3) for children ≥ 2 years and the UCLA PTSD Reaction Index (UCLA RI) for children ≥ 8 years.
Health Related Quality of Life
Standardized instruments to assess (in person, over the phone, or via mail) health related quality of life in children. Parent and child questionnaires.
Functional Status
Survey of overall functional status, administrated by asking a series of questions to patient and families.
Respiratory Status Questionnaire
Survey of respiratory health, administrated by asking a series of questions to patient and families.
Locations (1)
Children's Hospital Los Angeles
Los Angeles, California, United States