Long Term Follow up of Children Enrolled in the REDvent Study

NCT ID: NCT03709199

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 176 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2026-05-01

Brief 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

Study Design

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

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.

Intervention Type: DIAGNOSTIC_TEST

Diaphragm Ultrasound

Diaphragm thickness and contractile activity measured during tidal breathing.

Intervention Type: DIAGNOSTIC_TEST

Respiratory Inductance Plethysmography

Measure of thoraco-abdominal asynchrony during tidal breathing

Intervention Type: DIAGNOSTIC_TEST

Spirometry

Measurement of Forced Expiratory Volume (FEV1), Forced Vital Capacity and other lung volumes using standard pulmonary function techniques

Intervention Type: DIAGNOSTIC_TEST

Functional Residual Capacity

Measurement using body box plethysmography of functional residual capacity and other lung volumes using standard pulmonary function techniques

Intervention Type: DIAGNOSTIC_TEST

MIP/MEP

Measurement of maximal inspiratory and expiratory pressures during airway occlusion

Intervention Type: DIAGNOSTIC_TEST

6 minute walk test

Measurement of cardio-respiratory function and capabilities during treadmill walking for 6 minutes.

Intervention Type: 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).

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Functional Status

Survey of overall functional status, administrated by asking a series of questions to patient and families.

Intervention Type: DIAGNOSTIC_TEST

Respiratory Status Questionnaire

Survey of respiratory health, administrated by asking a series of questions to patient and families.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Lung Clearance Index; Phase Angle; Pulmonary Function Tests; Pulmonary Function Tests; PEDS-QL; Functional Status Scale

Eligibility Criteria

Inclusion Criteria

1. Children > 1 month (at least 44 weeks Corrected Gestational Age) and ≤ 18 years of age AND

2. Supported on mechanical ventilation for pulmonary parenchymal disease (i.e., pneumonia, bronchiolitis, Pediatric Acute Respiratory Distress Syndrome (PARDS)) with Oxygen Saturation Index (OSI) ≥ 5 or Oxygenation Index (OI) ≥4 115 AND

3. Who are within 48 hours of initiation of invasive mechanical ventilation (allow for up to 72 hours for those transferred from another institution) AND

4. Enrolled in the REDvent Study

Exclusion Criteria

1. Contraindications to use of an esophageal catheter (i.e. severe mucosal bleeding, nasal encephalocele, transphenoidal surgery) OR

2. Contraindications to use of RIP bands (i.e. omphalocele, chest immobilizer or cast) OR

3. Conditions precluding diaphragm ultrasound measurement (i.e. abdominal wall defects, pregnancy) OR

4. Conditions precluding conventional methods of weaning (i.e., status asthmaticus, severe lower airway obstruction, critical airway, intracranial hypertension, Extra Corporeal Life Support (ECLS), intubation for UAO, tracheostomy, DNR, severe chronic respiratory failure, spinal cord injury above lumbar region, cyanotic heart disease (unrepaired or palliated)) OR

5. Primary Attending physician refuses (will be cleared with primary attending before approaching the patient) OR

6. Death in the ICU OR

7. New DNR orders during acute illness in ICU OR

8. Primary Language not English or Spanish OR

9. Children in foster care or a ward of the state.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Robinder Khemani

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robinder Khemani, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Locations

Children's Hospital Los Angeles

Los Angeles, California, United States

Countries

United States

Other Identifiers

CHLA-18-00354

Identifier Type: -

Identifier Source: org_study_id