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

Not Applicable
Completed
Conditions
Other Specified Respiratory Problems in Fetus or Neonate
Interventions
Other: NAVA level
Registration Number
NCT02048280
Lead Sponsor
ProMedica Health System
Brief 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
15
Inclusion Criteria
  • Neonates on NAVA ventilation
Exclusion Criteria

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
IntubatedNAVA levelNAVA level from 0.1 to 3
Primary Outcome Measures
NameTimeMethod
Changes in breakpoint in intubated and extubated patients20 minute study pre and post extubation

NAVA titration study will be done pre and post extubation to determine and then compare the breakpoint.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Promedica Toledo CHildren's Hospital NICU

🇺🇸

Toledo, Ohio, United States

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