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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.

NCT ID: NCT02018666

Last Updated: 2013-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-08-31

Brief Summary

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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

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Conditions

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Acute Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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spontaneous NAVA mode

Group Type EXPERIMENTAL

NAVA endotracheal tube

Intervention Type DEVICE

Inspiratory pressure support (IPS)

Group Type ACTIVE_COMPARATOR

NAVA endotracheal tube

Intervention Type DEVICE

Interventions

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NAVA endotracheal tube

Intervention Type DEVICE

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinact

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hopital L'Archet 1

Nice, Alpes Maritimes, France

Site Status

Hopital de la CROIX ROUSSE

Lyon, Auvergne-Rhône-Alpes, France

Site Status

Centre Hospitalier Lyon Sud

Lyon, Auvergne-Rhône-Alpes, France

Site Status

Hopital PELLEGRIN

Bordeaux, Gironde, France

Site Status

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

Pessac, Gironde, France

Site Status

Hôpital Dupuytren

Limoges, Haute Vienne, France

Site Status

Hopital Saint-Eloi - CHU MONTPELLIER

Montpellier, Herault, France

Site Status

Hopital Larrey- CHU D'ANGERS

Angers, Maine Et Loire, France

Site Status

Hopital de la Cote de Nacre - CHU de CAEN

Caen, Normandy, France

Site Status

Hopital d'Estaing

Clermont-Ferrand, Puy de Dome, France

Site Status

Hôpital de la Pitié Salpetrière

Paris, Île-de-France Region, France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 27686347 (View on PubMed)

Other Identifiers

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2011-A00559-32

Identifier Type: OTHER

Identifier Source: secondary_id

N° 2011-001

Identifier Type: -

Identifier Source: org_study_id