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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.

17. december 2013 opdateret af: Clinact

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

129

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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;

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: spontaneous NAVA mode
Enhed: NAVA endotracheal tube
Aktiv komparator: Inspiratory pressure support (IPS)
Enhed: NAVA endotracheal tube

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluate the benefit of NAVA mode as compared to IPS mode in terms of duration of spontaneous ventilation 48 hours after inclusion.
Tidsramme: 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.
Continuous recording during 48 hours following the intubation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Reduction of patient / ventilator disharmony, measured during the first 48 hours with the disharmony index
Tidsramme: Continuous recording during the first 48 hours
Continuous recording during the first 48 hours
Real-time spent in NAVA mode and frequency of returns in a controlled mode (controlled ventilation VAC).
Tidsramme: 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
Continuous recording during the first 48 hours
Earnings on the "breathing comfort"
Tidsramme: Continuous recording during the first 48 hours
Continuous recording during the first 48 hours
Earnings on sleep architecture
Tidsramme: 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.
Continuous recording during the first 48 hours
Tolerance
Tidsramme: 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.
Continuous for the duration of ICU stay, an expected maximum of 14 days

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of implementation failure of the NAVA endotracheal tube.
Tidsramme: 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
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
Tidsramme: Continuous recording until extubation or D14 maximum
Continuous recording until extubation or D14 maximum
Number of Permanent discontinuation of NAVA ventilation mode
Tidsramme: Continuous recording during the first 48 hours
Continuous recording during the first 48 hours
Comfort of the device measured by a visual analog scale.
Tidsramme: At the extubation or at D14 maximum
Tolerance of the device
At the extubation or at D14 maximum
Side effects associated with the use of the system
Tidsramme: Continuous for the duration of ICU stay, an expected maximum of 14 days
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Clinact

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2012

Primær færdiggørelse (Faktiske)

1. august 2013

Studieafslutning (Faktiske)

1. august 2013

Datoer for studieregistrering

Først indsendt

11. december 2013

Først indsendt, der opfyldte QC-kriterier

17. december 2013

Først opslået (Skøn)

23. december 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. december 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. december 2013

Sidst verificeret

1. december 2013

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • N° 2011-001
  • 2011-A00559-32 (Anden identifikator: ANSM)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Akut respirationssvigt

Kliniske forsøg med NAVA endotracheal tube

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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