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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Tongji University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Zhang Xiangyu, Tongji University
ClinicalTrials.gov Identifier:
NCT01186874
First received: August 9, 2010
Last updated: October 25, 2011
Last verified: July 2010
  Purpose

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.


Condition
Acute Lung Injury
Acute Respiratory Distress Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by Tongji University:

Estimated Enrollment: 100
Study Start Date: September 2010
Estimated Study Completion Date: November 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01186874

Contacts
Contact: Xiangyu Zhang, MD 86-21-66307174 xiangyu62@126.com
Contact: Qixing Wang, RT 86-21-66307153 wangqixing1221@163.com

Locations
China, Shanghai
Shanghai Tenth People's Hospital Recruiting
Shanghai, Shanghai, China, 200072
Contact: Xiangyu Zhang, MD    862166307174    xiangyu62@126.com   
Sponsors and Collaborators
Tongji University
Investigators
Principal Investigator: Xiangyu Zhang, MD Shanghai 10th People's Hospital
  More Information

No publications provided

Responsible Party: Zhang Xiangyu, Director, professor, Tongji University
ClinicalTrials.gov Identifier: NCT01186874     History of Changes
Other Study ID Numbers: OARSIS20100808
Study First Received: August 9, 2010
Last Updated: October 25, 2011
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Lung Injury
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014