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OpenTrials
Completed

NCT Number: NCT01161875

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Pitie Salpetriere, Department of Anesthesiology and Critical Care

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 postoperative ventilatory dysfunction following abdominal aortic surgery

Exclusion criteria

  • Contra-indication to non-invasive ventilation pregnancy.

Treatment and study plan

Neurally Adjusted Ventilatory Assistance

Device

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

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

Official study title

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

Acronym: NAVAHELMET

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 14, 2010
Registry last updated
Aug 5, 2011

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.