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.

Study Overview
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Brief Summary
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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.

Official Title
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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).

Conditions
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Acute Respiratory Failure

Intervention / Treatment
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* Device: NAVA endotracheal tube


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: spontaneous NAVA mode<br> | Device: NAVA endotracheal tube<br> <br> |
| Active Comparator: Inspiratory pressure support (IPS)<br> | Device: NAVA endotracheal tube<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the benefit of NAVA mode as compared to IPS mode in terms of duration of spontaneous ventilation 48 hours after inclusion. | 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. | Continuous recording during 48 hours following the intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of patient / ventilator disharmony, measured during the first 48 hours with the disharmony index |  | Continuous recording during the first 48 hours | 
| Real-time spent in NAVA mode and frequency of returns in a controlled mode (controlled ventilation VAC). | Feasibility of the initiation of mechanical ventilation in NAVA mode and feasibility of prolonged mechanical ventilation in NAVA mode | Continuous recording during the first 48 hours | 
| Earnings on the breathing comfort |  | Continuous recording during the first 48 hours | 
| Earnings on sleep architecture | Total sleep time; Number of arousals per hour; Duration of stage IV sleep ; Duration of Rapid Eye Movement (REM) sleep. | Continuous recording during the first 48 hours | 
| Tolerance | 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. | Continuous for the duration of ICU stay, an expected maximum of 14 days |