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NCT01504373 · ClinicalTrials.gov registry record
Regional Distribution Differences Between Neurally Adjusted Ventilatory Assist and Pressure Support Ventilation
A clinical trial, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- 4
- Enrollment target
NCT01504373: Completed study, sponsored by Boston Children's Hospital.
NCT01504373 is a clinical trial that has completed, run by Boston Children's Hospital. The registered enrollment target is 4 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01504373 has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- 4 participants
- Enrollment target
Study Summary
Neurally adjusted ventilatory assist (NAVA) is an FDA approved mode of mechanical ventilation. This mode of ventilation is currently in routine use in adult, pediatric and neonatal intensive care units. The electrical activity of the diaphragm, the largest muscle used during inspiration, is measured. The ventilator triggers (synchronizes patient effort) and applies proportional assistance based on measured electrical activity of the diaphragm (Edi). This electrical activity is measured through a feeding tube that also has a multiple-array esophageal electrode in it. This mode of ventilation has been proven to be equivalent to pressure support ventilation (PSV). Theoretically, the breath-to-breath control offered by NAVA may not only trigger faster and synchronize better, but provide the support deemed appropriate by the central nervous center on demand. Traditionally in the intensive care unit (ICU), pressure support is applied to subject breathing spontaneously. Pressure is set to achieve a given tidal volume. The influence of changing lung compliance not only from the lung disease itself, but the interactions of the respiratory muscles can drastically change minute ventilation and contribute to hyper- or hypoventilation. These changes are typically found on assessment of end-tidal carbon dioxide (CO2), blood gas, or oxygen saturation (SpO2) monitoring; all of which are potentially preventable if we allowed the central nervous system to control the ventilator. NAVA may allow us to couple the central nervous system (neuro-coupling) with the ventilator to provide real-time proportional assistance, reduce work of breathing and apply physiologic breathing patterns.
Primary Outcome
Regional distribution difference measured by EIT. Area and upper to lower lung volume ratios (as determined with EIT) will be the primary data analyzed. Global and regional filling of the lung will be compared during pressure support ventilation and neurally adjusted ventilatory assist.
Interventions
- DEVICE Neurally Adjusted Ventilatory Assist (NAVA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2011-05 |
| Est. Completion | 2020-04 |
What the finished NCT01504373 record still lists
NCT01504373 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 4 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Neurally Adjusted Ventilatory Assist (NAVA) is the first listed.
NCT01504373 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01504373 about?
NCT01504373 is a clinical study titled "Regional Distribution Differences Between Neurally Adjusted Ventilatory Assist and Pressure Support Ventilation". Neurally adjusted ventilatory assist (NAVA) is an FDA approved mode of mechanical ventilation. This mode of ventilation is currently in routine use in adult, pediatric and neonatal intensive care units. The electrical activity of the diaphragm, the largest muscle used during inspiration, is measured...
What is the current status of trial NCT01504373?
This trial is currently completed. The enrollment target is 4 participants. The study started on 2011-05. Estimated completion is 2020-04.
What interventions are being tested in trial NCT01504373?
The interventions under investigation include: Neurally Adjusted Ventilatory Assist (NAVA) (DEVICE).
Who is sponsoring clinical trial NCT01504373?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
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