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NCT03266016 · ClinicalTrials.gov registry record · NA
Real-time Effort Driven VENTilator Management
A NA study of Pediatric Respiratory Diseases and Ventilation Therapy; Complications, sponsored by Children's Hospital Los Angeles.
- Completed
- Registry status
- NA
- Development phase
- 248
- Enrollment target
- 1
- Study location
NCT03266016 is a NA study of Pediatric Respiratory Diseases and Ventilation Therapy; Complications that has completed, run by Children's Hospital Los Angeles. The registered enrollment target is 248 participants, above the 41-participant average among 3 other Pediatric Respiratory Diseases trials with a reported enrollment target (505% higher). The trial reports 1 study location across 1 state.
The verdict
NCT03266016, a NA study of Pediatric Respiratory Diseases and Ventilation Therapy; Complications, has completed, sponsored by Children's Hospital Los Angeles.
- COMPLETED
- Registry status
- NA
- Development phase
- 248 participants
- Enrollment target
- 1
- Study location
Study 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 respiratory muscle weakness in critically ill children, and test whether a novel computer-based approach (Real-time Effort Driven ventilator management (REDvent)) can preserve respiratory muscle strength and reduce time on MV. REDvent offers systematic recommendations to reduce controlled ventilation during the acute phase of MV, and uses real-time measures from esophageal manometry to adjust supported ventilator pressures such that patient effort of breathing remains in a normal range during the ventilator weaning phase. This phase II clinical trial is expected to enroll 276 children with pulmonary parenchymal disease, anticipated to be ventilated \> 48 hrs. Patients will be randomized to REDvent-acute vs. usual care for the acute phase of MV (interval from intubation to first spontaneous breathing trial (SBT)). Patients in either group who fail their first Spontaneous Breathing Trial (SBT), will also be randomized to REDvent-weaning vs. usual care for the weaning phase of MV (interval from first SBT to passing SBT). The primary clinical outcome is length of weaning (time from first SBT until successful passage of an SBT or extubation (whichever comes first)). Mechanistic outcomes surround multi-modal serial measures of respiratory muscle capacity (PiMax), load (resistance, compliance), effort (esophageal manometry), and architecture (ultrasound) throughout the course of MV. Upon completion, this study will provide important information on the pathogenesis and timing of respiratory muscle weakness during MV in children and whether this weakness can be mitigated by promoting more normal patient effort during MV via the use of REDvent. This will form the basis for a larger, Phase III multi-center study, powered for key clinical outcomes such as 28-day Ventilator Free Day
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Diaphragm Ultrasound
- OTHER Computerized Ventilator Protocol
- DIAGNOSTIC_TEST Esophageal Manometry
- DIAGNOSTIC_TEST Respiratory Inductance Plethysmography (RIP)
- DIAGNOSTIC_TEST Maximal Inspiratory Pressure
Study Locations (1)
California
- Children's Hospital Los Angeles - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 248 participants |
| Start Date | 2017-10-21 |
| Est. Completion | 2024-06-20 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03266016
The ClinicalTrials.gov registry entry for NCT03266016 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 248 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 41-participant average among 3 other Pediatric Respiratory Diseases trials with a reported enrollment target (505% higher). The listed sponsor is Children's Hospital Los Angeles, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Pediatric Respiratory Diseases appearing as the primary indexed condition, and to 5 interventions - of which Diaphragm Ultrasound is the first listed.
NCT03266016 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT03266016 about?
NCT03266016 is a clinical study titled "Real-time Effort Driven VENTilator Management". 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 respiratory muscle weakness in critically ill children, and test whether a novel computer-based appr...
What is the current status of trial NCT03266016?
This trial is currently completed. It is a NA study. The enrollment target is 248 participants. The study started on 2017-10-21. Estimated completion is 2024-06-20.
What conditions does trial NCT03266016 study?
This clinical trial studies the following conditions: Pediatric Respiratory Diseases, Ventilation Therapy; Complications, Diaphragm Disease.
What interventions are being tested in trial NCT03266016?
The interventions under investigation include: Diaphragm Ultrasound (DIAGNOSTIC_TEST), Computerized Ventilator Protocol (OTHER), Esophageal Manometry (DIAGNOSTIC_TEST), Respiratory Inductance Plethysmography (RIP) (DIAGNOSTIC_TEST), Maximal Inspiratory Pressure (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03266016?
This trial is sponsored by Children's Hospital Los Angeles, which has 119 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03266016 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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