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Epidemiology of Acute Respiratory Distress Syndrome in Chinese ICUs

13 juni 2020 bijgewerkt door: Peking Union Medical College Hospital

The acute respiratory distress syndrome(ARDS)has a high morbidity and mortality in patients admitted to intensive care units(ICUs). It represents a significant public health issue. No large nationwide, multicenters study of ARDS has been conducted in China. The purposes of this study are to analyse: 1)the incidence and outcomes of ARDS in ICU; 2) factors associated the mortality ; and 3) risk factors for development of ARDS .

Studie Overzicht

Toestand

Voltooid

Conditie

Acute respiratory distress syndrome

Gedetailleerde beschrijving

All patients admitted to the participating ICUs during a 6-month period(from January 1, 2015 to July 1,2015 ) will be screened at ICU admission and daily for the occurrence of ARDS ( AECC criteria) for a maximum of 28 days after ICU admission.

Data collection:

For all patients, Demographic characteristics, admission category, the patient source intervention during ICU , APACHEII , SOFA score and discharge information will be collected
For patients with ARDS, data about ABG , parameters of MV, hemodynamic on day0 to day7 and last day of MV will be collected.
For patients without ARDS at ICU admission, data about risk factor for ARDS ,such as LIPS score, parameters of MV , and fluid balance on ICU day0 to day7 will be collected.

Studietype

Observationeel

Inschrijving (Werkelijk)

2530

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

China
- Beijing
  - Beijing, Beijing, China
    - Peking University People's Hospital
  - Beijing, Beijing, China, 100730
    - MICU, Peking union medical college hospital
  - Beijing, Beijing, China
    - Beijing Hospital of Ministry of Health
  - Beijing, Beijing, China
    - Department of Critical Care Medicine, Fuxing Hospital, Capital Medical University
  - Beijing, Beijing, China
    - General ICU, Beijing Tongren Hospital, Capital Medical University
  - Beijng, Beijing, China
    - China-Japan Friendship Hospital
- Chongqing
  - ChongQing, Chongqing, China
    - Department of Emergency and Intensive Care Medicine, The First Affiliated Hospital of Chongqing Medical University
- Fujian
  - Fuzhou, Fujian, China
    - The First Affiliated Hospital Of Fujian Medical University
- Guangdong
  - Guangzhou, Guangdong, China
    - Department of CriticalCare Medicine, Guangdong General Hospital
- Hainan
  - HaiKou, Hainan, China
    - Department of Critical Care Medicine, Hainan Provincial People's Hospital
- Hebei
  - Shijiazhuang, Hebei, China
    - Department of Critical Care Medicine, Hebei Medical University Fourth Hospital
- Heilongjiang
  - Harbin, Heilongjiang, China
    - Department of Critical Care Medicine, The First Affiliated Hospital of Harbin Medical University
- Henan
  - Zhengzhou, Henan, China
    - ICU, The First Affiliated Hospital, Zhengzhou University
- Hubei
  - WuHan, Hubei, China
    - Department of Critical Care Medicine, Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology
- Hunan
  - Changsha, Hunan, China
    - Department of Critical Care Medicine, Xiangya Hospital, Central South University
- Inner Mongolia
  - Hohhot, Inner Mongolia, China
    - Department of Critical Care Medicine, The Affiliated Hopsital of Inner Mongolia Medical University
- Jilin
  - ChangChun, Jilin, China
    - Department of Critical Care Medicine, The Second Hospital of Jilin University
- Liaoning
  - Shenyang, Liaoning, China
    - Department of Critical Care Medicine, The First Affiliated Hospital of China Medical University
- Ningxia
  - YinChuan, Ningxia, China
    - General Hospital of Ningxia Medical University
- Shandong
  - Jinan, Shandong, China
    - Department of Critical Care Medicine, Qilu Hospital of Shandong University
- Shanghai
  - Shanghai, Shanghai, China
    - Emergency ICU, Ruijin Hospital, Shanghai Jiao Tong University
- Shanxi
  - XiAn, Shanxi, China
    - Surgical Intensive Care Unit, Xijing Hospital
- Sichuan
  - Chengdu, Sichuan, China
    - Department of Critical Care Medicine, West China Hospital, Sichuan University
- Xinjiang
  - Urumqi, Xinjiang, China
    - Department of Critical Care Medicine, First Affiliated Hospital, Xinjiang Medical University
- Yunnan
  - Kunming, Yunnan, China
    - Department of Emergency Medicine and Medical ICU, The First Affiliated Hospital of Kunming Medical University
- Zhejiang
  - Hangzhou, Zhejiang, China
    - Department of Critical Care Medicine, Zhejiang Provincial People's Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

All patients admitted to the participating ICUs during a 6-month period(from January 1, 2015 to July 1,2015 )

Beschrijving

Inclusion Criteria:

all patients age >18 yrs admitted to 24 participating ICUs

Exclusion Criteria:

No patients should be excluded (regardless of age, underlying disease, life expectancy, etc).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
ARDS, non-ARDS patients with ARDS and patients without ARDS

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
incidence of acute respiratory distress syndrome (ARDS) Tijdsspanne: from ICU admission to 28-day of ICU stay	incidence of ARDS = the number of patients developing ARDS during ICU / the total number of patients admitted to ICU	from ICU admission to 28-day of ICU stay

Secundaire uitkomstmaten

Uitkomstmaat	Tijdsspanne
ICU mortality of patients with ARDS Tijdsspanne: followed up to 3 months after inclusion or to ICU discharge, whichever occurred first	followed up to 3 months after inclusion or to ICU discharge, whichever occurred first
hospital mortality of patients with ARDS Tijdsspanne: followed up to 3 months after inclusion or to hospital discharge, whichever occurred first	followed up to 3 months after inclusion or to hospital discharge, whichever occurred first

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Peking Union Medical College Hospital

Onderzoekers

Hoofdonderzoeker: Bin Du, MICU of Peking Union Medical College Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 januari 2015

Primaire voltooiing (Werkelijk)

1 augustus 2015

Studie voltooiing (Werkelijk)

1 december 2015

Studieregistratiedata

Eerst ingediend

18 mei 2015

Eerst ingediend dat voldeed aan de QC-criteria

1 juli 2015

Eerst geplaatst (Schatting)

3 juli 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 juni 2020

Laatste update ingediend die voldeed aan QC-criteria

13 juni 2020

Laatst geverifieerd