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OpenTrials
Completed

NCT Number: NCT01280760

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

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

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Key information

Conditions

Weaning Period

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Pitié Salpétrière, Department of intensive care and pneumology

Paris, 75013, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Device: Neurally Adjusted Ventilatory Assistance

Other

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

Primary outcomes

  1. Triggering delay

    Time frame: Every inspiration, for 10 minutes

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

Secondary outcomes

  1. Cycling off delay

    Time frame: Every inspiration, for 10 minutes

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

Sponsors and collaborators

Lead sponsor

Pierre and Marie Curie University

Other

Registry information

Acronym: NAVA-NIV

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 21, 2011
Registry last updated
Dec 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.