NCT03709199

Long Term Follow up of Children Enrolled in the REDvent Study

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)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 176 (actual)
• Sponsor: Children's Hospital Los Angeles · Academic / Other
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Distress Syndrome, Adult
• Ventilator-Induced Lung Injury
• Neurocognitive Dysfunction
• Quality of Life
• Respiration Disorders

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	Diaphragm Ultrasound	Diaphragm thickness and contractile activity measured during tidal breathing.
DIAGNOSTIC_TEST	Respiratory Inductance Plethysmography	Measure of thoraco-abdominal asynchrony during tidal breathing
DIAGNOSTIC_TEST	Spirometry	Measurement of Forced Expiratory Volume (FEV1), Forced Vital Capacity and other lung volumes using standard pulmonary function techniques
DIAGNOSTIC_TEST	Functional Residual Capacity	Measurement using body box plethysmography of functional residual capacity and other lung volumes using standard pulmonary function techniques
DIAGNOSTIC_TEST	MIP/MEP	Measurement of maximal inspiratory and expiratory pressures during airway occlusion
DIAGNOSTIC_TEST	6 minute walk test	Measurement of cardio-respiratory function and capabilities during treadmill walking for 6 minutes.
DIAGNOSTIC_TEST	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).
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	Functional Status	Survey of overall functional status, administrated by asking a series of questions to patient and families.
DIAGNOSTIC_TEST	Respiratory Status Questionnaire	Survey of respiratory health, administrated by asking a series of questions to patient and families.

Timeline

• Start date: 2018-10-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2018-10-17
• Last updated: 2025-04-17

Locations

1 site across 1 country: United States