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

ProMedica Health System

Status: Completed

Conditions: Other Specified Respiratory Problems in Fetus or Neonate

Treatments: Other: NAVA level

Study type: Interventional

Funder types: Other

Identifiers

NCT02048280

TCH02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 23 to 40 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Neonates on NAVA ventilation

Exclusion criteria

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Intubated

Experimental group

Description:

NAVA level from 0.1 to 3

Treatment:

Other: NAVA level

Other: NAVA level