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.

Not Applicable

Completed

• Conditions: Acute Respiratory Failure
• Interventions: Device: NAVA endotracheal tube

• Registration Number: NCT02018666
• Lead Sponsor: Clinact

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-12
• Study First Submitted: 2013-12-11
• Study First Submitted QC: 2013-12-17
• Last Update Submitted: 2013-12-17
• Study First Posted: 2013-12-23
• Last Update Posted: 2013-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
spontaneous NAVA mode	NAVA endotracheal tube	-
Inspiratory pressure support (IPS)	NAVA endotracheal tube	-

Primary Outcome Measures

Name	Time	Method
Evaluate the benefit of NAVA mode as compared to IPS mode in terms of duration of spontaneous ventilation 48 hours after inclusion.	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 Outcome Measures

Name	Time	Method
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).	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
Earnings on the "breathing comfort"	Continuous recording during the first 48 hours
Earnings on sleep architecture	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.
Tolerance	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.

Trial Locations

Locations (11)

Hôpital Dupuytren; 🇫🇷 Limoges, Haute Vienne, France

Hôpital de la Pitié Salpetrière; 🇫🇷 Paris, Ile de France, France

Hopital Larrey- CHU D'ANGERS; 🇫🇷 Angers, Maine Et Loire, France

Centre Hospitalier Lyon Sud; 🇫🇷 Lyon, Rhone Alpes, France

Groupe Hospitalier Sud - Hôpital Haut-Leveque - Maison du Haut-Leveque; 🇫🇷 Pessac, Gironde, France

Hopital L'Archet 1; 🇫🇷 Nice, Alpes Maritimes, France

Hopital Saint-Eloi - CHU MONTPELLIER; 🇫🇷 Montpellier, Herault, France

Hopital d'Estaing; 🇫🇷 Clermont Ferrand, Puy de Dome, France

Hopital de la CROIX ROUSSE; 🇫🇷 Lyon, Rhone Alpes, France

Hopital PELLEGRIN; 🇫🇷 Bordeaux, Gironde, France

Hopital de la Cote de Nacre - CHU de CAEN; 🇫🇷 Caen, Normandie, France