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Ultrasound to Evaluate Failure of Liberation From Mechanical Ventilation (USEFUL)

26. marts 2019 opdateret af: Ewan Goligher, University Health Network, Toronto
This study will evaluate the heart, lungs and diaphragm of patients who fail a trial of spontaneous breathing to determine the physiological mechanism of weaning failure.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

The transition to unassisted breathing after invasive ventilation often proves challenging, with over 40% of patients failing their first attempt of unassisted breathing. Persistent ventilator dependence predisposes patients to nosocomial complications and increases the economic burden of critical illness. Ventilator-dependence results from an imbalance between the load and capacity of the respiratory muscle pump. Patients who fail a trial of spontaneous breathing commonly exhibit excess respiratory loads secondary to weaning-induced pulmonary edema, atelectasis or dynamic hyperinflation. Many patients who are dependent on the ventilator also show a striking loss of pump capacity due to diaphragm dysfunction. Though each of these mechanisms respond to specific interventions, it is often difficult for physicians to discern which mechanisms are at play at the bedside. Bedside ultrasound is a potentially useful means of evaluating cardiac, pulmonary and diaphragm function during weaning failure. It is readily available, highly feasible and already widely employed in clinical practice. As yet, no study has evaluated the accuracy and feasibility of combining echocardiography with lung and diaphragm ultrasound to comprehensively evaluate the physiological mechanisms of weaning failure. The objectives of this study are to establish the utility of a rapid thoracic ultrasound exam to diagnose mechanisms of ventilation liberation failure and to assess the relationship between cardiothoracic variability during spontaneous breathing and different physiological mechanism of weaning failure.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

7

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital
      • Toronto, Ontario, Canada, M5G 2N2
        • University Health Network

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

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients in the intensive care unit.

Beskrivelse

Inclusion Criteria:

  • patients over 18 years of age receiving invasive mechanical ventilation for at least 24 hours
  • patients who fulfill standard criteria for readiness for a trial of spontaneous breathing (no or minimal sedation, patient awake and interactive; minimal vasopressor/inotrope requirements (Norepinephrine < or = 0.1, Dopamine < 10, Vasopressin/Epinephrine off); fraction of inspired oxygen < or = 50%; spontaneous inspiratory efforts as indicated by patient-triggered breaths; positive end-expiratory pressure < or = 10 cm H20)
  • patients who fail a trial of spontaneous breathing (transient reduction of ventilator support for any duration up to 2 hours as per local ICU practice - typically PS 5 with PEEP 5 OR CPAP 5 OR T-piece)

Exclusion Criteria:

  • patients with a coagulopathy (INR > 2.5, platelet count < 30x10^6/L) or previously diagnosed bleeding diathesis or are receiving anticoagulant drugs at therapeutic doses (ie. excluding venous thromboembolic prophylaxis)
  • patients with a contraindication to nasogastric tube insertion (esophageal varices, upper GI tract surgery, facial trauma, etc.)
  • patients receiving extra-corporeal life support

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sensitivity and specificity for diagnosis of physiological mechanisms causing weaning failure
Tidsramme: Physiological measurements for diagnostic classification measured simultaneously with ultrasound measurements
Mechanisms responsible for weaning failure will be diagnosed by field experts using clinical data collected from the chart along with physiological measurements (respiratory mechanics, maximal inspiratory pressure, markers of pulmonary edema including changes in serum total protein and BNP and central venous pressure). The diagnosis derived from a pre-specified ultrasound-based classification system will be compared to the gold standard expert-derived diagnosis.
Physiological measurements for diagnostic classification measured simultaneously with ultrasound measurements

Samarbejdspartnere og efterforskere

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

Sponsor

University Health Network, Toronto

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. april 2014

Primær færdiggørelse (Faktiske)

1. december 2018

Studieafslutning (Faktiske)

1. december 2018

Datoer for studieregistrering

Først indsendt

24. marts 2016

Først indsendt, der opfyldte QC-kriterier

24. marts 2016

Først opslået (Skøn)

30. marts 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. marts 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. marts 2019

Sidst verificeret

1. marts 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 14-7400-B

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 .

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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