- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01186874
Epidemiology Research on Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) in Adult ICU in Shanghai
Studieoversigt
Status
Betingelser
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
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Xiangyu Zhang, MD
- Telefonnummer: 86-21-66307174
- E-mail: xiangyu62@126.com
Undersøgelse Kontakt Backup
- Navn: Qixing Wang, RT
- Telefonnummer: 86-21-66307153
- E-mail: wangqixing1221@163.com
Studiesteder
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Shanghai
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Shanghai, Shanghai, Kina, 200072
- Rekruttering
- Shanghai Tenth People's Hospital
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Kontakt:
- Xiangyu Zhang, MD
- Telefonnummer: 862166307174
- E-mail: xiangyu62@126.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Xiangyu Zhang, MD, Shanghai 10th People's Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- OARSIS20100808
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