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Completed

NCT Number: NCT01928238

Physiologic Effects of Noninvasive Neurally Adjusted Ventilatory Assist (NAVA) Versus Noninvasive Pressure Support Ventilation in Patients at Risk for Respiratory Distress Needed Preventive Used of Noninvasive Ventilation After Extubation.

The purpose of this study is to compare inspiratory effort, comfort, gas exchange and patient ventilator synchrony during non-invasive neurally adjusted ventilatory assist or pneumatically triggered and cycled-off noninvasive pressure support ventilation (NPSV), in patient at risk of respiratory distress after extubation.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux

Bordeaux, 33000, France

About this study

Reintubation, which occurs after planned extubation, is a relevant consequence of respiratory failure after extubation. The early use of noninvasive pressure support ventilation averted respiratory failure after extubation in patients at increased risk. However patient tolerance to the technique is a critical factor determining its success. One of the key factors determining tolerance to Non Invasive Ventilation (NIV) is optimal synchrony between the patient's spontaneous breathing activity and the ventilator's settings, known as patient ventilator interaction. Optimal patient-ventilator synchrony during NIV can prove very difficult to achieve due to the presence of leaks, the type of interface which can interfere with various aspects of ventilator function. Patient ventilator synchrony during NPSV can be compromised when using conventional pneumatic triggering, with the ventilator-delivered inspiratory support starting after the patient's inspiratory effort. The switch from inspiration to expiration (cycling-off) should, ideally, coincide with the end of the patient's inspiratory effort. However greater asynchrony at the end of inspiration, with the ventilator cycling off either too early or too late compared to the end of the patient's inspiratory effort can be observed during NPSV. A possible solution is to replace the pneumatic triggering with neural triggering and cycling off using the diaphragm electrical activity (Eadi). Neurally adjusted ventilatory assist (NAVA) uses the electrical activity of the diaphragm to control the timing and pressure of the ventilation delivered. The ventilator is triggered, limited and cycled-off directly by Eadi. The Eadi is measured by a multiple array oesophageal electrode. The array of bipolar electrodes can be mounted on a feeding tube, which is routinely introduced in critically ill patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients intubated for 48 h or more
  • Patients who tolerated a 120-min spontaneous breathing trial after recovery from their acute disease with no signs of respiratory failure
  • Patients at high risk for respiratory after extubation were enrolled if they had at least two of the following risk factors for respiratory failure after extubation:
  • age older than 65 years
  • Chronic obstructive pulmonary disease,
  • heart failure as the cause for intubation
  • An Acute Physiology and Chronic Health Evaluation (APACHE)-II score greater than 12 on the day of extubation.

Exclusion criteria

  • Age younger than 18 years
  • Head trauma or surgery
  • Recent gastric or oesophageal surgery
  • Active upper gastrointestinal bleeding
  • Excessive amount of respiratory secretions
  • Poor cooperation
  • Decision to limit life-supporting treatments in the ICU
  • Tracheostomy or other upper airway disorders
  • Lack of collaboration
  • Do not resuscitate order or any decision to limit therapeutic effort in the ICU.

Treatment and study plan

Noninvasive neurally adjusted ventilatory assist (NIV-NAVA).

Device

Noninvasive pressure support ventilation (NPSV)

Device

Primary outcomes

  1. Inspiratory muscle effort

    Time frame: At inclusion (day 0)

    The primary endpoint variable is the inspiratory muscle effort. To estimate the inspiratory effort, we will determine the transdiaphragmatic pressure (Pdi), the transdiaphragmatic pressure time product per breath (PTPdi/b) or per minute (PTPdi/min) and the Electrical Activity of the Diaphragm (EADI)max.

Secondary outcomes

  1. patient ventilator synchrony

    Time frame: At inclusion (Day 0)

    Patient ventilator synchrony will be identified by estimating the following variables: autocycled breaths, ineffective inspiratory effort, the inspiratory trigger delay, the expiratory trigger delay and the time of synchrony between muscle effort and ventilator support.

  2. gas exchange

    Time frame: At inclusion (Day 0)

  3. Patient comfort

    Time frame: At inclusion (Day 0)

    Patient comfort will be assessed using a five-item semi quantitative scale: 1, uncomfortable; 2, somewhat uncomfortable; 3, acceptable; 4, somewhat comfortable; and 5, comfortable.

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: NAVA-VNI

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Aug 23, 2013
Registry last updated
May 22, 2026

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.

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