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.

NCT02018666 | Completed

• 2 other identifiers: N° 2011-0012011-A00559-32
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 11

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.

Conditions

Acute Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• Earnings on the "breathing comfort"

  Continuous recording during the first 48 hours

• Earnings on sleep architecture

  Continuous recording during the first 48 hours

• Tolerance

  Continuous for the duration of ICU stay, an expected maximum of 14 days

Other Outcomes (5)

• 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

Study Arms (2)

spontaneous NAVA mode

EXPERIMENTAL

Device: NAVA endotracheal tube

Inspiratory pressure support (IPS)

ACTIVE COMPARATOR

Device: NAVA endotracheal tube

Interventions

NAVA endotracheal tube DEVICE

Inspiratory pressure support (IPS); spontaneous NAVA mode

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 ;
• Therapeutic limitation or active treatment discontinuation;
• Pregnant women;
• Minors;
• Protected adults;
• Patient already included in the study;

Sponsors & Collaborators

• Clinact: lead

Study Sites (11)

Hopital L'Archet 1

Nice, Alpes Maritimes, 06202, France

Location

Hopital de la CROIX ROUSSE

Lyon, Auvergne-Rhône-Alpes, 69004, France

Location

Centre Hospitalier Lyon Sud

Lyon, Auvergne-Rhône-Alpes, 69495, France

Location

Hopital PELLEGRIN

Bordeaux, Gironde, 33076, France

Location

Groupe Hospitalier Sud - Hôpital Haut-Leveque - Maison du Haut-Leveque

Pessac, Gironde, 33604, France

Location

Hôpital Dupuytren

Limoges, Haute Vienne, 87042, France

Location

Hopital Saint-Eloi - CHU MONTPELLIER

Montpellier, Herault, 34295, France

Location

Hopital Larrey- CHU D'ANGERS

Angers, Maine Et Loire, 49933, France

Location

Hopital de la Cote de Nacre - CHU de CAEN

Caen, Normandy, 14000, France

Location

Hopital d'Estaing

Clermont-Ferrand, Puy de Dome, 63100, France

Location

Hôpital de la Pitié Salpetrière

Paris, Île-de-France Region, 75651, France

Location

Related Publications (1)

• 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.

  PMID: 27686347 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2013
• First Posted: December 23, 2013
• Study Start: January 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: December 23, 2013

Record last verified: 2013-12

Locations

FR (11)