Clinical trial 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.
Official 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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Failure
Lead sponsor: Clinact
Sponsor class: OTHER
First posted: 2013-12-23
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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:

  1. norepinephrine \> 0.3 mcg / kg / min;
  2. 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:

  1. Recent gastrointestinal suture ;
  2. 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;

Primary outcomes:
measure: Evaluate the benefit of NAVA mode as compared to IPS mode in terms of duration of spontaneous ventilation 48 hours after inclusion.
timeFrame: Continuous recording during 48 hours following the intubation
Secondary outcomes:
measure: Reduction of patient / ventilator disharmony, measured during the first 48 hours with the disharmony index
timeFrame: Continuous recording during the first 48 hours
measure: Real-time spent in NAVA mode and frequency of returns in a controlled mode (controlled ventilation VAC).
timeFrame: Continuous recording during the first 48 hours
measure: Earnings on the "breathing comfort"
timeFrame: Continuous recording during the first 48 hours
measure: Earnings on sleep architecture
timeFrame: Continuous recording during the first 48 hours
measure: Tolerance
timeFrame: Continuous for the duration of ICU stay, an expected maximum of 14 days
Other outcomes:
measure: Number of implementation failure of the NAVA endotracheal tube.
timeFrame: 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
measure: Number and duration of automatic switch into IPS mode
timeFrame: Continuous recording until extubation or D14 maximum
measure: Number of Permanent discontinuation of NAVA ventilation mode
timeFrame: Continuous recording during the first 48 hours
measure: Comfort of the device measured by a visual analog scale.
timeFrame: At the extubation or at D14 maximum
measure: Side effects associated with the use of the system
timeFrame: Continuous for the duration of ICU stay, an expected maximum of 14 days
Locations:
city: Nice
country: France
facility: Hopital L'Archet 1
state: Alpes Maritimes
city: Bordeaux
country: France
facility: Hopital PELLEGRIN
state: Gironde
city: Pessac
country: France
facility: Groupe Hospitalier Sud - Hôpital Haut-Leveque - Maison du Haut-Leveque
state: Gironde
city: Limoges
country: France
facility: Hôpital Dupuytren
state: Haute Vienne
city: Montpellier
country: France
facility: Hopital Saint-Eloi - CHU MONTPELLIER
state: Herault
city: Paris
country: France
facility: Hôpital de la Pitié Salpetrière
state: Ile de France
city: Angers
country: France
facility: Hopital Larrey- CHU D'ANGERS
state: Maine Et Loire
city: Caen
country: France
facility: Hopital de la Cote de Nacre - CHU de CAEN
state: Normandie
city: Clermont Ferrand
country: France
facility: Hopital d'Estaing
state: Puy de Dome
city: Lyon
country: France
facility: Hopital de la CROIX ROUSSE
state: Rhone Alpes
city: Lyon
country: France
facility: Centre Hospitalier Lyon Sud
state: Rhone Alpes
Study officials:
References:
citation: Demoule A, Clavel M, Rolland-Debord C, Perbet S, Terzi N, Kouatchet A, Wallet F, Roze H, Vargas F, Guerin C, Dellamonica J, Jaber S, Brochard L, Similowski T. Neurally adjusted ventilatory assist as an alternative to pressure support ventilation in adults: a French multicentre randomized trial. Intensive Care Med. 2016 Nov;42(11):1723-1732. doi: 10.1007/s00134-016-4447-8. Epub 2016 Sep 30.