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

Sponsor

ProMedica Health System (Other)

Overall Status

Completed

CT.gov ID

NCT02048280

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Other Specified Respiratory Problems in Fetus or Neonate	Procedure: NAVA level Other: NAVA level	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Dec 1, 2012

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intubated NAVA level from 0.1 to 3	Procedure: NAVA level Peak inspiratory pressure will be measured at each NAVA level Other: NAVA level Increase NAVA level every 3 minutes

Arm

Intervention/Treatment

Experimental: Intubated

NAVA level from 0.1 to 3

Procedure: NAVA level

Peak inspiratory pressure will be measured at each NAVA level

Other: NAVA level

Increase NAVA level every 3 minutes

Outcome Measures

Primary Outcome Measures

Changes in breakpoint in intubated and extubated patients [20 minute study pre and post extubation]
NAVA titration study will be done pre and post extubation to determine and then compare the breakpoint.

Eligibility Criteria

Criteria

Ages Eligible for Study:

23 Weeks to 40 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Neonates on NAVA ventilation

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Promedica Toledo CHildren's Hospital NICU	Toledo	Ohio	United States	43606

Sponsors and Collaborators

ProMedica Health System

Investigators

Principal Investigator: Howard Stein, MD, Promedica Toledo Childrne's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ProMedica Health System

ClinicalTrials.gov Identifier:

NCT02048280

Other Study ID Numbers:

TCH02

First Posted:

Jan 29, 2014

Last Update Posted:

Jul 30, 2015

Last Verified:

Jul 1, 2015

Study Results

No Results Posted as of Jul 30, 2015