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OpenTrials
Completed

NCT Number: NCT04032288

Establish a Prospective Registration System of ARDS Patients for Improving Quality of Care

The registration system will enroll and follow up ARDS patients prospectively through screening patients with bilateral radiographic infiltrates and a PaO2/FiO2 ratio of 200 mmHg or less by respiratory therapist. The diagnosis of ARDS must be made by an intensivist or chest physician. Including characteristics, co-morbidities, clinical features, laboratory data, organs dysfunction, treatments and outcomes of ARDS patients will be recorded.

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Key information

Conditions

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Intensive Care Medicine; Chi Mei Medical Center

Tainan, 710, Taiwan

About this study

Acute respiratory distress syndrome (ARDS) is defined as a syndrome of acute and persistent lung inflammation with increased vascular permeability and characterized by three clinical features: bilateral radiographic infiltrates; a PaO2/FiO2 ratio of 200 mmHg or less, regardless of the level of PEEP and no clinical evidence for an elevated left atrial pressure. If measured, the pulmonary capillary wedge pressure is 18 mmHg or less. In 1994, the American-European Consensus Conference on acute respiratory distress syndrome (ARDS) issued the above definitions that have been widely used by clinicians and researchers (1, 2) When patients with acute respiratory distress syndrome (ARDS), an age-adjusted incidence of 64 per 100,000 person-years and a mortality of 41 percent were detected. Within intensive care units, approximately ten to 15 percent of admitted patients and up to 20 percent of mechanically ventilated patients meet criteria for ARDS (3-6). The mortality rate varies on the basis of the underlying cause, with most patients dying of multi-organ system failure rather than isolated respiratory insufficiency (5, 7). Large trials suggest that the overall mortality of ARDS ranges from 26 to 58 percent (8, 9). The better outcomes always came from tertiary medical centers or big clinical trials, which somewhat might conceal the fact of presence of higher mortality. The mortality rate in our hospital ever reached or even up to 67.2%(10). To improve the quality of care in ARDS patients still has a long way to. We hope to establish a prospective registration system to understand the real status of quality of care first, and then quality improvement interventions will be followed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ARDS patients prospectively through screening patients with bilateral radiographic infiltrates and a PaO2/FiO2 ratio of 200 mmHg or less by respiratory therapist.

Exclusion criteria

  • NA.

Treatment and study plan

Primary outcomes

  1. mortality

    Time frame: 1 year

    Hospital Mortality Rate

Sponsors and collaborators

Lead sponsor

Chimei Medical Center

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Jul 25, 2019
Registry last updated
Jul 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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