Status:
COMPLETED
Real-time Effort Driven VENTilator Management
Lead Sponsor:
Children's Hospital Los Angeles
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Children's Hospital of Philadelphia
Conditions:
Ventilation Therapy; Complications
Diaphragm Disease
Eligibility:
All Genders
30-18 years
Phase:
NA
Brief Summary
This study is a Phase II controlled clinical trial that will obtain comprehensive, serial assessments of respiratory muscle strength and architecture to understand the evolution of ventilator-induced ...
Detailed Description
Study Aims: SA1: To determine if REDvent acute and/or weaning phase protocols can shorten the duration of weaning from MV (Primary outcome). SA2: To determine if changes to direct measures of respir...
Eligibility Criteria
Inclusion
- Children \> 1 month (\>44 weeks CGA) and ≤ 18 years of age AND
- Supported on mechanical ventilation with pulmonary parenchymal disease (i.e., pneumonia, bronchiolitis, Pediatric Acute Respiratory Distress Syndrome (PARDS)) with Oxygen Saturation Index (OSI) ≥ 5 or Oxygenation Index (OI) ≥) AND
- Who are within 48 hours of initiation of invasive mechanical ventilation (allow for up to 72 hours for those transferred from another institution)
Exclusion
- Contraindications to use of an esophageal catheter (i.e. severe mucosal bleeding, nasal encephalocele, transphenoidal surgery) OR
- Contraindications to use of RIP bands (i.e. omphalocele, chest immobilizer or cast) OR
- Conditions precluding diaphragm ultrasound measurement (i.e. abdominal wall defects, pregnancy) OR
- Conditions on enrollment that preclude conventional methods of weaning (i.e., status asthmaticus, severe lower airway obstruction, critical airway, intracranial hypertension, Extra Corporeal Life Support (ECLS), intubation for UAO, DNR, severe chronic respiratory failure, spinal cord injury above lumbar region, cyanotic heart disease (unrepaired or palliated)) OR
- Primary Attending physician refuses (will be cleared with primary attending before approaching the patient).
Key Trial Info
Start Date :
October 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2024
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT03266016
Start Date
October 21 2017
End Date
June 20 2024
Last Update
September 17 2025
Active Locations (1)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027