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Patient-ventilator Asynchrony During Mechanical Invasive Assisted-ventilation in Pediatric Patients (NavPed-Inv)

31. august 2010 opdateret af: University Hospital, Geneva

The purpose of this study is to document the prevalence and type of asynchronies incidence during invasive mechanical ventilation in pediatric patients breathing under pressure support.

And to observe the impact of adjusting the expiratory trigger setting on asynchronies, and compare these incidences with asynchronies measured in pediatric patient breathing under NAVA system (Neurally Adjusted Ventilatory Assist).

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Two sessions will be recorded, one in PSV, one with NAVA, delivered in a random order after being sure the infant is calm and comfortable, according to his parents and/or the nurse in charge.

Criteria for initiating invasive ventilation and to start PSV will follow the usual practice guidelines of the unit.

Ventilation parameters in PS will be adjusted by the clinician in charge of the patient, as usual based on clinical observation. Investigators will not interfere with ventilator settings. Ventilation will be applied via an endotracheal tube, uncuffed for the majority (if infant < 5 years), according to commonly applied guidelines in this unit.

One 15 minutes session will be recorded, after being sure the infant is calm and comfortable according to the parents and/or the nurse in charge. Then the clinician in charge of the patient will modify the ETS, first decreasing it of 10% below the initial set value, and will be recorded the following 5 minutes after stabilization and secondly increasing it of 10% above the initial set value, and will be recorded the following 5 minutes after stabilization.

NAVA will be set to deliver initially the same peak pressure (comparable level of assist) than during the initial PS period. Same PEEP will be delivered in both modes. This is possible with a pre-visualization window, allowing adjustments before switching to the NAVA mode. Nava ventilation will be recorded during 20 minutes.

The 2 sessions, Pressure support and Nava, will be recorded consecutively.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Schweiz
      • Geneva, Schweiz, 1211
        • Rekruttering
        • University Hospital of Geneva
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Peter Rimensberger, MD
        • Underforsker:
          • Laurence Vignaux
        • Underforsker:
          • Thomas Jaecklin, MD
        • Underforsker:
          • Serge Grazioli, MD
        • Underforsker:
          • Lise Piquilloud
        • Underforsker:
          • Philippe Jolliet, Pr
        • Underforsker:
          • Didier Tassaux, MD

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

4 uger til 12 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • all consecutive patients from 4 weeks to 12 years (post natal interm infants) admitted to the pediatric intensive care unit (PICU) and receiving mechanical ventilation in pressure support ventilation

Exclusion Criteria:

  • Non treated pneumothorax
  • Hemodynamic instability
  • At least 2 hours following the admission in the PICU in post cardiac surgery
  • FiO2 > 0.6
  • Poor short term prognosis (defined as a high risk of death in the next seven days)
  • contraindication for gastric tube or obtention of a reliable EMGdi signal
  • Known esophageal problem (hiatal hernia, esophageal varicosities)
  • Active upper gastro-intestinal bleeding or any other contraindication to the insertion of a naso-gastric tube
  • Neuromuscular disease
  • Patients with a pacemaker

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Pressure support

in this arm, pressure support will be recorded under 3 conditions:

  • with the initial Expiratory Trigger Setting (ETS)
  • with ETS +10%
  • with ETS -10%
Andet: Pressure Support
Ventilation under pressure support
Eksperimentel: NAVA
Neurally Adjusted ventilatory Assist is a ventilation mode where the ventilator is piloted by the electrical activity of the diaphragm Ventilation is triggered and cycled off by the electrical activity of the diaphragm, the pressure delivered being proportional to this activity.
Enhed: NAVA
Ventilation under NAVA

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
asynchronies
Tidsramme: 12 months

Asynchronies during mechanical ventilation are the following: Auto triggering, double triggering, late cycling, premature cycling and ineffective effort.

all ventilatory parameters are recorded under Pressure support (3 phases: 3 levels of expiratory trigger setting, initial, +10% and -10%, 15 min, 5 min and 5 min respectively) and NAVA (1 phase, 20 min).

Asynchronies will be determined by measuring each ventilatory cycle of all recordings.
12 months

Samarbejdspartnere og efterforskere

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

Sponsor

University Hospital, Geneva

Efterforskere

  • Ledende efterforsker: Peter Rimensberger, MD, University Hospital of Geneva

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. juni 2010

Primær færdiggørelse (Forventet)

1. juni 2011

Studieafslutning (Forventet)

1. juni 2011

Datoer for studieregistrering

Først indsendt

31. august 2010

Først indsendt, der opfyldte QC-kriterier

31. august 2010

Først opslået (Skøn)

1. september 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

1. september 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. august 2010

Sidst verificeret

1. august 2010

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • HUG-matped 09-253

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 Åndedræt, kunstig

Kliniske forsøg med Pressure Support

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