Clinical Trials Directory

Trials / Completed

CompletedNCT02048280

Comparing NAVA Levels in Intubated and Recently Extubated Neonates to Determine Optimal Non-invasive Ventilatory Support

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
15 (actual)
Sponsor
ProMedica Health System · Academic / Other
Sex
All
Age
23 Weeks – 40 Weeks
Healthy volunteers
Not accepted

Summary

Neurally adjusted ventilatory assist (NAVA) is a mode of mechanical ventilation that uses the diaphragm's normal electrical activity to deliver a mechanically supported breath. The amount of support provided is determined in part by the NAVA level, where a higher NAVA level will provide higher level of support and unload more of the work of the diaphragm. The purpose of this study is to compare the optimal NAVA level in neonates while on mechanical ventilation while intubated and after being extubated.

Detailed description

Baseline measurements will be taken. The NAVA titration study will then be done. The NAVA level will be set at a starting value of 0.1 cm H2O/mcV and systematically increased by 0.5 cm H2O/mcV every three minutes to a maximum of 3 cmH2O/mcV. Once the NAVA titration study has been completed, the patient will be extubated. There will be a stabilization period following extubation (15-30 minutes), and then the NAVA titration study will be repeated.

Conditions

Interventions

TypeNameDescription
PROCEDURENAVA levelPeak inspiratory pressure will be measured at each NAVA level
OTHERNAVA levelIncrease NAVA level every 3 minutes

Timeline

Start date
2012-12-01
Primary completion
2014-06-01
Completion
2015-04-01
First posted
2014-01-29
Last updated
2015-07-30

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02048280. Inclusion in this directory is not an endorsement.