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

NCT ID: NCT01161875

Last Updated: 2011-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non-Invasive Positive-Pressure Ventilation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Neurally Adjusted Ventilatory Assistance

In ICU following abdominal aortic surgery, in extubated patient, non-invasive ventilation was performed as follows:

* facial mask with non-invasive pressure support ventilation mode to define settings for helmet ventilation
* helmet use with non-invasive pressure support ventilation mode to define adequate settings
* helmet use with neurally adjusted ventilatory assist mode, based on previous settings

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Contra-indication to non-invasive ventilation pregnancy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pierre and Marie Curie University

OTHER

Sponsor Role lead

Responsible Party

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Groupe Hospitalier Pitie Salpetriere

Principal Investigators

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Thomas Similowski, MD, PhD

Role: STUDY_DIRECTOR

Groupe Hospitalier Pitie-Salpetriere

Mathieu RAUX, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Groupe Hospitalier Pitie-Salpetriere

Locations

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Groupe Hospitalier Pitie Salpetriere, Department of Anesthesiology and Critical Care

Paris, , France

Site Status

Countries

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France

Other Identifiers

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Nava Helmet #1

Identifier Type: -

Identifier Source: org_study_id

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