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.

Acute Respiratory Failure Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02018666
• Other study ID #: N° 2011-001
• Secondary ID: 2011-A00559-32
• Status: Completed
• Phase: N/A
• First received: December 11, 2013
• Last updated: December 17, 2013
• Start date: January 2012
• Est. completion date: August 2013

Study information

• Verified date: December 2013
• Source: Clinact
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Device:
• NAVA endotracheal tube

Locations

Country	Name	City	State
France	Hopital Larrey- CHU D'ANGERS	Angers	Maine Et Loire
France	Hopital PELLEGRIN	Bordeaux	Gironde
France	Hopital de la Cote de Nacre - CHU de CAEN	Caen	Normandie
France	Hopital d'Estaing	Clermont Ferrand	Puy de Dome
France	Hôpital Dupuytren	Limoges	Haute Vienne
France	Centre Hospitalier Lyon Sud	Lyon	Rhone Alpes
France	Hopital de la CROIX ROUSSE	Lyon	Rhone Alpes
France	Hopital Saint-Eloi - CHU MONTPELLIER	Montpellier	Herault
France	Hopital L'Archet 1	Nice	Alpes Maritimes
France	Hôpital de la Pitié Salpetrière	Paris	Ile de France
France	Groupe Hospitalier Sud - Hôpital Haut-Leveque - Maison du Haut-Leveque	Pessac	Gironde

Sponsors (1)

Lead Sponsor	Collaborator
Clinact

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Other	Number and duration of automatic switch into IPS mode		Continuous recording until extubation or D14 maximum	No
Other	Number of Permanent discontinuation of NAVA ventilation mode		Continuous recording during the first 48 hours	No
Other	Comfort of the device measured by a visual analog scale.	Tolerance of the device	At the extubation or at D14 maximum	Yes
Other	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	Yes
Primary	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	No
Secondary	Reduction of patient / ventilator disharmony, measured during the first 48 hours with the disharmony index		Continuous recording during the first 48 hours	No
Secondary	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	No
Secondary	Earnings on the "breathing comfort"		Continuous recording during the first 48 hours	No
Secondary	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	No
Secondary	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	Yes