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.

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).

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Failure
• Intervention / Treatment: Device: NAVA endotracheal tube

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Alpes Maritimes
    • Nice, Alpes Maritimes, France, 06202
      • Hôpital l'Archet 1
  • Gironde
    • Bordeaux, Gironde, France, 33076
      • Hôpital Pellegrin
    • Pessac, Gironde, France, 33604
      • Groupe Hospitalier Sud - Hôpital Haut-Leveque - Maison du Haut-Leveque
  • Haute Vienne
    • Limoges, Haute Vienne, France, 87042
      • Hopital Dupuytren
  • Herault
    • Montpellier, Herault, France, 34295
      • Hopital Saint-Eloi - CHU MONTPELLIER
  • Ile de France
    • Paris, Ile de France, France, 75651
      • Hopital de La Pitie Salpetriere
  • Maine Et Loire
    • Angers, Maine Et Loire, France, 49933
      • Hopital Larrey- CHU D'ANGERS
  • Normandie
    • Caen, Normandie, France, 14000
      • Hopital de la Cote de Nacre - CHU de CAEN
  • Puy de Dome
    • Clermont Ferrand, Puy de Dome, France, 63100
      • Hôpital d'Estaing
  • Rhone Alpes
    • Lyon, Rhone Alpes, France, 69004
      • Hôpital de La Croix Rousse
    • Lyon, Rhone Alpes, France, 69495
      • Centre Hospitalier Lyon Sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of implementation failure of the NAVA endotracheal tube.		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
Number and duration of automatic switch into IPS mode		Continuous recording until extubation or D14 maximum
Number of Permanent discontinuation of NAVA ventilation mode		Continuous recording during the first 48 hours
Comfort of the device measured by a visual analog scale.	Tolerance of the device	At the extubation or at D14 maximum
Side effects associated with the use of the system	Device movements Endotracheal tube obstruction Lesion of the oral or nasal mucosa	Continuous for the duration of ICU stay, an expected maximum of 14 days

Collaborators and Investigators

• Sponsor: Clinact

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: December 11, 2013
• First Submitted That Met QC Criteria: December 17, 2013
• First Posted (Estimate): December 23, 2013

Study Record Updates

• Last Update Posted (Estimate): December 23, 2013
• Last Update Submitted That Met QC Criteria: December 17, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Respiratory Insufficiency; Respiratory Distress Syndrome
• Other Study ID Numbers: N° 2011-001; 2011-A00559-32 (Other Identifier: ANSM)