Impact of Neurally Adjusted Ventilator Assist (NAVA) Mode on Patient Ventilator Asynchrony Using Helmet (NAVAHELMET)

Study of the Benefit of the NAVA Mode Versus PSV Mode on Patient Ventilator Asynchrony During Non Invasive Ventilation With Helmet

Non invasive ventilation has been proposed to reduce the incidence of ventilatory dysfunction following abdominal aortic surgery. However, the nasogastric tube reduces the airtightness of the facial mask used to perform non invasive ventilation and induces air leaks. The use of a helmet reduces air leaks, thus seems adequate to ensure patient-ventilator interface. However, the high dead space related to helmet volume is responsible for asynchrony between patient demand and ventilatory support delivery. The investigators hypothesized driving the ventilator based on a neural signal (diaphragm electrical activity) would reduce patient-ventilator asynchronies.

Study Overview

• Status: Completed
• Conditions: Non-Invasive Positive-Pressure Ventilation
• Intervention / Treatment: Device: Neurally Adjusted Ventilatory Assistance

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Groupe Hospitalier Pitie Salpetriere, Department of Anesthesiology and Critical Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Postoperative period

Description

Inclusion Criteria:

• Patients with increased risk of postoperative ventilatory dysfunction following abdominal aortic surgery

Exclusion Criteria:

• Contra-indication to non-invasive ventilation pregnancy.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Triggering delay	Duration between the onset of neural inspiration and the onset of insufflation	Every inspiration, for 10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cycling off delay	Delay between the end of neural inspiration and the end of insufflation	Every inspiration, for 10 minutes

Collaborators and Investigators

• Sponsor: Pierre and Marie Curie University
• Investigators: Study Director: Thomas Similowski, MD, PhD, Groupe Hospitalier Pitie-Salpetriere; Principal Investigator: Mathieu RAUX, MD, PhD, Groupe Hospitalier Pitie-Salpetriere

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: July 13, 2010
• First Submitted That Met QC Criteria: July 13, 2010
• First Posted (Estimate): July 14, 2010

Study Record Updates

• Last Update Posted (Estimate): August 5, 2011
• Last Update Submitted That Met QC Criteria: August 4, 2011
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: Nava Helmet #1