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Real-time Effort Driven VENTilator Management
NCT03266016 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 248 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Los Angeles, which has 163 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03266016 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03266016?
This trial is sponsored by Children's Hospital Los Angeles, which has 163 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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