Long Term Follow up of Children Enrolled in the REDvent Study

Children's Hospital Los Angeles

Status: Active, not recruiting

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

Treatments: Diagnostic Test: Functional Status; Diagnostic Test: 6 minute walk test; Diagnostic Test: MIP/MEP; Diagnostic Test: Respiratory Inductance Plethysmography; Diagnostic Test: Ventilation Inhomogeneity; Diagnostic Test: Emotional Health Assessment; Diagnostic Test: Health Related Quality of Life; Diagnostic Test: Diaphragm Ultrasound; Diagnostic Test: Spirometry; Diagnostic Test: Respiratory Status Questionnaire; Diagnostic Test: Functional Residual Capacity; Diagnostic Test: Neurocognitive Testing

Study type: Observational

Funder types: Other

Identifiers

NCT03709199

CHLA-18-00354

Details and patient eligibility

About

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.

Enrollment: 176 patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 (1-5 are REDvent exclusion):

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.