Clinical Trials Directory

Trials / Completed

CompletedNCT00583037

24-Hour NAVA Ventilation in Acute Respiratory Failure

FEASIBILITY OF 24 Hrs VENTILATION WITH NEURALLY ADJUSTED VENTILATORY ASSIST (NAVA) IN PATIENTS WITH ACUTE RESPIRATORY FAILURE

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
15 (estimated)
Sponsor
Unity Health Toronto · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Neurally Adjusted Ventilatory Assist (NAVA) is a new mode of mechanical ventilation that is controlled by the electrical activity of the diaphragm (EAdi). The EAdi is a signal that represents the patient's breathing effort, and hence with NAVA, the assist being delivered is synchronized and proportional to the demands of the patient. This is a prospective physiological study of the feasibility of NAVA ventilation over 24 hours. The aim is to demonstrate that NAVA can maintain spontaneous breathing and unload the respiratory muscles during both sleep and wake cycles over a 24 hour period.

Detailed description

To date, studies using NAVA technology have been limited to short term evaluations (under 3 hours). No serious adverse events have been observed in patients enrolled in our 3-hour study of NAVA in patients with acute lung injury. All 15 patients successfully tolerated the period of ventilation (i.e. there were no dropouts) with NAVA and the stability of the blood gas parameters over time reveals the efficiency of this new mode of ventilation in regards to oxygenation. A longer study may help to evaluate patient tolerance of NAVA and stability over time. A longer study will also demonstrate the feasibility of NAVA to adapt to changes in respiratory drive, changes in patient status, and the interventions of health care providers. A longer time frame should help us understand the parameters for titration of NAVA settings over time and establish some indications/limits for the future use of this promising technique. This intermediate study will generate the data necessary for the development of additional protocols to refine NAVA application and to compare NAVA to other assist modes.

Conditions

Interventions

TypeNameDescription
DEVICENeurally Adjusted Ventilatory Assist (NAVA)Mechanical ventilation controlled by diaphragm electrical activity

Timeline

Start date
2006-05-01
Primary completion
2008-01-01
Completion
2008-05-01
First posted
2007-12-31
Last updated
2009-06-01

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT00583037. Inclusion in this directory is not an endorsement.