Impact of Neurally Adjusted Ventilator Assist (NAVA) Mode on Patient Ventilator Asynchrony Using Non-invasive Ventilation (NAVA-NIV)

• Sponsor: Pierre and Marie Curie University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01280760
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Duration (Months): 3.9
• Patients Per Site Per Month: 4.1

Study Details

Study Description

Brief Summary

Non-invasive ventilation (NIV) has been proposed to reduce the incidence of ventilatory dysfunction following mechanical ventilation weaning. However, the nasogastric tube reduces the airtightness of the facial mask used to perform non-invasive ventilation and induces air leaks. The presence of leaks at the patient-mask interface can increase the risk of patient-ventilator asynchrony, which in turn leads to increase patient discomfort. Neurally adjusted ventilatory assist (NAVA)could contribute to decreasing asynchrony. Its principle is to record the diaphragmatic electrical activity and to control the ventilator. The investigators hypothesized driving the ventilator based on a neural signal (diaphragm electrical activity) would reduce patient-ventilator asynchronies in NIV

Condition or Disease	Intervention/Treatment	Phase
Weaning Period	Other: Device: Neurally Adjusted Ventilatory Assistance

Study Design

• Study Type: Observational
• Actual Enrollment: 16 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Impact of Neurally Adjusted Ventilator Assist (NAVA) Mode on Patient Ventilator Asynchrony Using Non-invasive Ventilation (NAVA-NIV)
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Non invasive ventilation Non-invasive ventilation after invasive mechanical ventilation weaning	Other: Device: Neurally Adjusted Ventilatory Assistance; Device: Neurally Adjusted Ventilatory Assistance In ICU following extubation NIV was performed as follows: facial mask with PSV/NIV mode to define settings for NAVA ventilation facial use with NAVA/NIV mode

Outcome Measures

Primary Outcome Measures

1. Triggering delay [Every inspiration, for 10 minutes]

   Duration between the onset of neural inspiration and the onset of insufflation

Secondary Outcome Measures

1. Cycling off delay [Every inspiration, for 10 minutes]

   Delay between the end of neural inspiration and the end of insufflation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Patients with increased risk of post-extubation ventilatory dysfunction following invasive mechanical ventilation weaning.

Exclusion Criteria:

• Contra-indication to non-invasive ventilation

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Groupe Hospitalier Pitié Salpétrière, Department of intensive care and pneumology	Paris		France	75013

Sponsors and Collaborators

• Pierre and Marie Curie University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Matthieu SCHMIDT, Dr, Pierre and Marie Curie University
• ClinicalTrials.gov Identifier: NCT01280760
• Other Study ID Numbers: UPMC
• First Posted: Jan 21, 2011
• Last Update Posted: Dec 19, 2013
• Last Verified: Dec 1, 2013

Study Results

No Results Posted as of Dec 19, 2013