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Local Assessment of Management of Burn Patients (LAMiNAR)

26. juni 2017 opdateret af: Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Local Assessment of Management of Burn Patients (LAMiNAR) - a Prospective Observational International Multicenter Cohort Study

In the general intensive care unit (ICU) population, there is strong evidence for benefit from lung-protective mechanical ventilation, including the use of low tidal volumes and adequate levels of positive end-expiratory pressure (PEEP). In burn patients it is highly uncertain whether these settings are beneficial and there are even concerns over safety of, in particular use of low tidal volumes. There is lack of international guidelines and consequently ventilation practice in burn patients may widely vary.

The primary objective is to determine ventilation practice in burn ICUs worldwide, focusing on the size of tidal volumes and the levels of PEEP used for burn patients. In addition, data on other strategies considered important in patients who receive ventilation are also collected, including data on neuromuscular blocking agents, sedatives and analgesics, and type and amount of intravenous fluids used in the period of ventilation. The secondary objective is to determine the association between tidal volume size and levels of PEEP, and duration of ventilation in burn patients.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Patient population: Consecutive burn patients admitted to participating burn ICUs who receive invasive ventilation, irrespective of severity of burn injury and/or presence of inhalation trauma are eligible for participation.

Data collection: includes burn patients admitted within a period of three months. Demographic and baseline data are collected from the clinical files on the day of admission. If available, standard of care and clinical outcome parameters are collected daily until day 14, death or discharge from ICU, whatever comes first.

Sample size: The primary objective is to determine (variations in) ventilation practice in burn patients in burn ICUs. Therefore, the sample size is based on the main secondary objective, which is to determine the association between the following ventilator settings: tidal volume, PEEP, FiO2 and mode; and outcome of burn patients. The investigators calculated the sample size for a multiple regression model: a sample size of at least 300 patients is required to have a power of 0.80, a significance level of 0.05, using an estimated effect size of 0.04, while using 4 independent variables in the model.

Ethics Approval: National coordinators will be responsible for clarifying the need for ethics approval and applying for this where appropriate according to local policy. Centres will not be permitted to record data unless ethics approval or an equivalent waiver is in place. The investigators expect that in most, if not every participating country, a patient informed consent is not be required.

Monitoring: Due to the observational nature of the study, a DSMB is not necessary.

Organization: National co-ordinators will lead the project within individual nations and identify participating hospitals, translate study paperwork, distribute study paperwork and ensure necessary regulatory approvals are in place. They provide assistance to the participating clinical sites in trial management, record keeping and data management. Local coordinators in each site will supervise data collection and ensure adherence to Good Clinical Practice during the trial.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

300

Kontakter og lokationer

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

Studiesteder

  • Holland
    • Zuid Holland
      • Amsterdam, Zuid Holland, Holland, 1105AZ
        • Academic Medical Center

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

Sandsynlighedsprøve

Studiebefolkning

Consecutive intubated and ventilated burn patients admitted to participating ICUs during a period of 3 months

Beskrivelse

Inclusion Criteria:

  • Burns
  • Admission to a participating burn ICU Need for invasive ventilation
  • Informed consent (only if applicable in the country where data are collected)

Exclusion Criteria:

  • None

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
Ventilation parameters
Tidsramme: Up to 14 days during mechanical ventilation
Tidal volume size; milliliters per kilogram of predicted body weight
Up to 14 days during mechanical ventilation
Ventilation parameters
Tidsramme: Up to 14 days during mechanical ventilation
Level of positive end-expiratory pressure (PEEP); cm H2O
Up to 14 days during mechanical ventilation
Ventilation parameters
Tidsramme: Up to 14 days during mechanical ventilation
Fraction of oxygen in inspired air (FiO2), %
Up to 14 days during mechanical ventilation
Ventilation parameters
Tidsramme: Up to 14 days during mechanical ventilation
Mode of ventilation; assist-control or spontaneous modes of ventilation
Up to 14 days during mechanical ventilation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Opholdslængde på intensivafdeling på dag 90
Tidsramme: Indtil dag 90
Tid mellem indlæggelse og udskrivelse eller død
Indtil dag 90
Længde af hospitalsophold på dag 90
Tidsramme: Indtil dag 90
Tid mellem indlæggelse og udskrivelse eller død
Indtil dag 90
ICU-dødelighed af alle årsager
Tidsramme: Indtil dag 90
Ethvert dødsfald under intensivophold
Indtil dag 90
Hospitalsdødelighed af alle årsager
Tidsramme: Indtil dag 90
Ethvert dødsfald under hospitalsophold
Indtil dag 90
Number of ventilator-free days and alive at day 28
Tidsramme: From day 1 to day 28
Defined as the number of days, from day 1 to day 28, the patient is alive and breathes without assistance of a mechanical ventilator, if the period of unassisted breathing lasted at least 24 consecutive hours. Notably, if after successful withdrawal of mechanical ventilation the patient requires ventilation for a surgical procedure, this will not count as a 'ventilator day'. If ventilation is prolonged after surgery due to respiratory insufficiency, the day(s) ventilation is required counts as a 'ventilator day'
From day 1 to day 28
Other Ventilation Parameters
Tidsramme: Up to 14 days during mechanical ventilation
Peak and plateau pressures or maximum airway pressure
Up to 14 days during mechanical ventilation
Other Ventilation Parameters
Tidsramme: Up to 14 days during mechanical ventilation
Respiratory rate
Up to 14 days during mechanical ventilation
Other Ventilation Parameters
Tidsramme: Up to 14 days during mechanical ventilation
Inspiration to expiration ratio
Up to 14 days during mechanical ventilation
Other Ventilation Parameters
Tidsramme: Up to 14 days during mechanical ventilation
Peripheral oxygen saturation
Up to 14 days during mechanical ventilation
Other Ventilation Parameters
Tidsramme: Up to 14 days during mechanical ventilation
Arterial blood gas parameters
Up to 14 days during mechanical ventilation
Need for Tracheostomy
Tidsramme: daily up to 14 days from inclusion
Need for tracheostomy, first tracheostomy will be assessed up to 14 days from inclusion
daily up to 14 days from inclusion
Daily Lung Injury Scores
Tidsramme: Up to 14 days during mechanical ventilation
Score based on chest X-ray findings (if obtained), PaO2/FiO2, PEEP level and respiratory compliance.
Up to 14 days during mechanical ventilation
Daily Sequential Organ Failure Assessment (SOFA)-scores
Tidsramme: Daily up to 14 days from inclusion
six-organ dysfunction/failure score measuring multiple organ failure daily
Daily up to 14 days from inclusion
Complications
Tidsramme: Daily up to 14 days from inclusion
Complications will include: Skin and soft tissue infections
Daily up to 14 days from inclusion
Complications
Tidsramme: Daily up to 14 days from inclusion
Complications will include: (Ventilator associated) Pneumonia
Daily up to 14 days from inclusion
Complications
Tidsramme: Daily up to 14 days from inclusion
Complications will include: Sepsis
Daily up to 14 days from inclusion
Complications
Tidsramme: Daily up to 14 days from inclusion
Complications will include: Acute respiratory distress syndrome according to Berlin criteria
Daily up to 14 days from inclusion
Complications
Tidsramme: Daily up to 14 days from inclusion
Complications will include: Acute renal failure
Daily up to 14 days from inclusion
Complications
Tidsramme: Daily up to 14 days from inclusion
Complications will include: Abdominal compartment syndrome
Daily up to 14 days from inclusion

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Standard care strategies
Tidsramme: Daily up to 14 days from inclusion
Strategies considered to be important in patients who receive ventilation, including: Fluid balance, types and dose of fluids used
Daily up to 14 days from inclusion
Standard care strategies
Tidsramme: Daily up to 14 days from inclusion
Strategies considered to be important in patients who receive ventilation, including: use of sedative and analgesic drugs
Daily up to 14 days from inclusion
Standard care strategies
Tidsramme: Daily up to 14 days from inclusion
Strategies considered to be important in patients who receive ventilation, including: use of sedation and delirium scores
Daily up to 14 days from inclusion
Standard care strategies
Tidsramme: Daily up to 14 days from inclusion
Strategies considered to be important in patients who receive ventilation, including: use of neuromuscular blocking agents
Daily up to 14 days from inclusion
Standard care strategies
Tidsramme: Daily up to 14 days from inclusion
Strategies considered to be important in patients who receive ventilation, including: use of antibiotic prophylaxis
Daily up to 14 days from inclusion

Samarbejdspartnere og efterforskere

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

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Efterforskere

  • Ledende efterforsker: Marcus J. Schultz, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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

Hjælpsomme links

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. september 2015

Primær færdiggørelse (Faktiske)

1. maj 2017

Studieafslutning (Faktiske)

1. maj 2017

Datoer for studieregistrering

Først indsendt

4. december 2014

Først indsendt, der opfyldte QC-kriterier

7. december 2014

Først opslået (Skøn)

9. december 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. juni 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. juni 2017

Sidst verificeret

1. juni 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LAMiNAR

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