CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 22 enrolled
Drug / intervention
Neurally Adjusted Ventilatory Assist +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02518230
NCT02518230N/ACompleted

Respiratory Severity and Caloric Consumption on NAVA: Randomized Crossover Trial of NAVA and SIMV

Children's Mercy Hospital Kansas City·interventional·Posted Aug 7, 2015·Updated Jul 23, 2021

In Brief

A clinical study evaluating Neurally Adjusted Ventilatory Assist and Synchronized Interm. Mandatory Assist for Respiratory Insufficiency and Infant, Newborn, Disease. Completed, enrolled 22 participants across 1 site.

Detailed Summary

This study is a single center, prospective cohort crossover study comparing mechanically ventilated neonates and infants on Neurally Adjusted Ventilatory Assist (NAVA) and synchronized intermittent mandatory ventilation with pressure control plus pressure support (SIMV(PC) + PS) modes. This design will allow for direct comparison of two commonly used ventilator modalities in the neonatal intensive care unit (NICU) to determine if one mode is superior to the other with regards to respiratory mechanics and estimated energy expenditure. It is hypothesized that neonates and infants will have improved respiratory severity score (MAP X FiO2) utilizing NAVA compared to the SIMV (PC) + PS mode but will have increased estimated energy expenditure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 7, 2015
Enrollment StartJan 1, 2014
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 10.9 years ago

Interventions

Neurally Adjusted Ventilatory Assistdevice

The subject will be crossed over from the baseline ventilator mode to Neurally Adjusted Ventilatory Assist

Synchronized Interm. Mandatory Assistdevice

The subject will be crossed over from the baseline ventilator mode to Synchronized Intermittent Mandatory Assist with Pressure Support