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

Acute Respiratory Distress Syndrome Clinical Trial

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01186874
• Other study ID #: OARSIS20100808
• Status: Unknown status
• Phase: N/A
• First received: August 9, 2010
• Last updated: October 25, 2011
• Start date: September 2010
• Est. completion date: November 2011

Study information

• Verified date: July 2010
• Source: Tongji University
• Contact: Xiangyu Zhang, MD
• Phone: 86-21-66307174
• Email: xiangyu62[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 100
• Est. completion date: November 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Locations

Country	Name	City	State
China	Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Tongji University

Country where clinical trial is conducted

China,