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Completed

NCT Number: NCT02018666

Study Comparing Two Ventilation Modes NAVA (Neurally Adjusted Ventilatory Assist) Mode and Spontaneous Breathing With Inspiratory Pressure Support (IPS) Mode in Consecutive Patients Hospitalized for Acute Respiratory Failure Requiring Mechanical Ventilation With Endotracheal Tube.

This is a multicenter, prospective, randomized, open-label study which compared two ventilation modes: spontaneous NAVA mode and spontaneous breathing with IPS mode (the latter is considered as the reference ventilatory mode) in patients admitted to the ICU for acute respiratory failure and ventilated with an endotracheal tube. NAVA mode allows to minimize patient-ventilator disharmony with acceptable tolerance and to preserve spontaneous ventilation.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital L'Archet 1, Nice, Alpes Maritimes, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient ventilated with endotracheal tube for more than 24 hours
  • Return for at least 30 minutes to spontaneous ventilation allowing IPS with a level of pressure support <30 cm H2O;
  • Level of sedation =< 4 on the Ramsay scale in the absence of medical decision to increase the level of sedation;
  • Fraction of inspired oxygen (FiO 2) =< 50% with a positive end-expiratory pressure (PEEP) =< 8 cm H2O;
  • Absence of administration of high-dose vasopressor therapy defined by:
  • norepinephrine > 0.3 mcg / kg / min;
  • dopamine > 10 mcg / kg / min;
  • Estimated duration of mechanical ventilation > 48h00

Exclusion criteria

  • Contraindication to the implementation of the NAVA endotracheal tube, ie any contraindication to the implementation of a gastric tube or to the repositioning of a tube already in place:
  • Recent gastrointestinal suture ;
  • Esophageal varices rupture with gastrointestinal bleeding within 4 days prior to inclusion;
  • Therapeutic limitation or active treatment discontinuation;
  • Pregnant women;
  • Minors;
  • Protected adults;
  • Patient already included in the study;

Treatment and study plan

NAVA endotracheal tube

Device

Primary outcomes

  1. Evaluate the benefit of NAVA mode as compared to IPS mode in terms of duration of spontaneous ventilation 48 hours after inclusion.

    Time frame: Continuous recording during 48 hours following the intubation

    The time spent in different modes of spontaneous ventilation (NAVA, IPS) and controlled ventilation (VAC controlled pressure) will be measured. The primary endpoint will be the proportion of patients remaining in spontaneous ventilation after the first 48 hours.

Secondary outcomes

  1. Reduction of patient / ventilator disharmony, measured during the first 48 hours with the disharmony index

    Time frame: Continuous recording during the first 48 hours

  2. Real-time spent in NAVA mode and frequency of returns in a controlled mode (controlled ventilation VAC).

    Time frame: Continuous recording during the first 48 hours

    Feasibility of the initiation of mechanical ventilation in NAVA mode and feasibility of prolonged mechanical ventilation in NAVA mode

  3. Earnings on the "breathing comfort"

    Time frame: Continuous recording during the first 48 hours

  4. Earnings on sleep architecture

    Time frame: Continuous recording during the first 48 hours

    Total sleep time; Number of arousals per hour; Duration of stage IV sleep ; Duration of Rapid Eye Movement (REM) sleep.

  5. Tolerance

    Time frame: Continuous for the duration of ICU stay, an expected maximum of 14 days

    • Adverse events associated with the use of the device.
    • Incidence of ventilator-acquired pneumonia.
    • Duration of ICU stay.
    • Duration of hospital stay.
    • Mortality in the ICU.
    • Hospital mortality.

Other outcomes

  1. Number of implementation failure of the NAVA endotracheal tube.

    Time frame: For each patient, the success or failure of the endotracheal tube implementation will be evaluated, this for the entire duration of the study estimated to 18 months

  2. Number and duration of automatic switch into IPS mode

    Time frame: Continuous recording until extubation or D14 maximum

  3. Number of Permanent discontinuation of NAVA ventilation mode

    Time frame: Continuous recording during the first 48 hours

  4. Comfort of the device measured by a visual analog scale.

    Time frame: At the extubation or at D14 maximum

    Tolerance of the device

  5. Side effects associated with the use of the system

    Time frame: Continuous for the duration of ICU stay, an expected maximum of 14 days

    Device movements Endotracheal tube obstruction Lesion of the oral or nasal mucosa

Sponsors and collaborators

Lead sponsor

Clinact

Other

Registry information

Official study title

ZEPHYR: Multicenter, Prospective, Randomized, Open-label Study in Consecutive Patients Hospitalized for Acute Respiratory Failure Requiring Mechanical Ventilation With Endotracheal Tube. This Study Compared Two Ventilation Modes: NAVA Mode and Spontaneous Breathing With Inspiratory Pressure Support (the Latter is Considered as the Reference Ventilation Mode).

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 23, 2013
Registry last updated
Dec 23, 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.

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