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

• Sponsor: Pierre and Marie Curie University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01161875
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Duration (Months): 13
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Invasive Positive-Pressure Ventilation	Device: Neurally Adjusted Ventilatory Assistance

Study Design

• Study Type: Observational
• Anticipated Enrollment: 10 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Study of the Benefit of the NAVA Mode Versus PSV Mode on Patient Ventilator Asynchrony During Non Invasive Ventilation With Helmet
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

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 and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• Contra-indication to non-invasive ventilation pregnancy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Groupe Hospitalier Pitie Salpetriere, Department of Anesthesiology and Critical Care	Paris		France	75013

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01161875
• Other Study ID Numbers: Nava Helmet #1
• First Posted: Jul 14, 2010
• Last Update Posted: Aug 5, 2011
• Last Verified: Nov 1, 2009

Study Results

No Results Posted as of Aug 5, 2011