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Epidemiology Research on Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) in Adult ICU in Shanghai

25. oktober 2011 opdateret af: Zhang Xiangyu, Tongji University
To survey the prevalence and the mortality of the Acute Lung Injury/ Acute Respiratory Distress Syndrome (ALI/ARDS) in 12 university hospital ICUs in Shanghai.

Studieoversigt

Detaljeret beskrivelse

Acute lung injury is a critical illness syndrome consisted of acute hypoxemic respiratory failure with bilateral pulmonary infiltrates that are not attributed to left atrial hypertension. The severity of the hypoxemia differentiates these two entities, with a ratio of partial pressure of oxygen in arterial blood (PaO2) to inspired fraction of oxygen (FIO2) of less than 200 mm Hg for ARDS and of less than 300 mm Hg for ALI.[1] Although ARDS initially was reported in 1967 by Ashbaugh and colleagues[2], it was not until 1992 that the American-European Consensus Conference (AECC) on ARDS developed a standardized definition for ARDS and ALI. There are many epidemiologic researches about the incidence and mortality of the ALI/ARDS.[3-6] Gorden D [3] reported that a total of 1113 King County residents undergoing mechanical ventilation met the criteria for acute lung injury and were 15 years of age or older. On the basis of this figure, the crude incidence of acute lung injury was 78.9 per 100,000 person-years and the age-adjusted incidence was 86.2 per 100,000 person-years. The in-hospital mortality rate was 38.5 percent. In our country, Yueming Lu [7] reported in-hospital and 90-day mortalities of ARDS patients were 68.5 and 70.4% in Shanghai ICU in 2004.

In recent years, significant progress has been made in the diagnosis and treatment of the ALI/ARDS, such as the application of the lung protective ventilation strategy and the CRRT, which may prove the symptoms and the prognosis of the ALI/ARDS. However, controversies still remained. Ventilation drive pressure, early application of neuromuscular blockade, strategy of PEEP level are frequently met questions in routine practice. In our country, a guideline for the treatment and diagnosis of ALI/ARDS was developed in 2006 [8]. So the incidence and the mortality of this disease are unknown in our country now. Therefore, the investigators will perform a prospective, multi-center study to survey the incidence, risk factors and outcome of ALI/ARDS in 13 adult ICU in Shanghai.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

100

Kontakter og lokationer

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Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

    • Shanghai
      • Shanghai, Shanghai, Kina, 200072
        • Rekruttering
        • Shanghai Tenth People's Hospital
        • Kontakt:

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

16 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

All consecutive patients with ALI/ARDS who are admitted to the study ICUs

Beskrivelse

Inclusion Criteria:

  • All consecutive patients with ALI/ARDS who are admitted to the study ICUs between 1st Aug. 2010 at 00:00 hours (midnight) and the finish date of 31st Jan. 2011 at 23:59 hours (11.59 pm). Patients who are already in the ICUs prior to 1st Aug. 2010 at 00:00 hours will not be included in the study.

Exclusion Criteria:

  • Patients less than 15 years old.
  • Patients with the organ transplantation, end-stage of the malignant tumors and brain death.
  • The GCS of the patient is less than 8.
  • Patients with severe sepsis who were directly transferred to the study ICUs from another hospital or another ICU.
  • For all patients who are discharged from the ICU and readmitted to the ICU again during the study period, only the first admission during the study period will be included.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Xiangyu Zhang, MD, Shanghai 10th People's Hospital

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 2010

Primær færdiggørelse (Faktiske)

1. marts 2011

Studieafslutning (Forventet)

1. november 2011

Datoer for studieregistrering

Først indsendt

9. august 2010

Først indsendt, der opfyldte QC-kriterier

20. august 2010

Først opslået (Skøn)

23. august 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. oktober 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. oktober 2011

Sidst verificeret

1. juli 2010

Mere information

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 Acute respiratory distress syndrom

3
Abonner