Clinical trial NCT04032288: Establish a Prospective Registration System of ARDS Patients for Improving Quality of Care
Official title: Establish a Prospective Registration System of ARDS Patients for Improving Quality of Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mortality
Keywords: ARDS
Low tidal volume ventilation
Outcomes
Lead sponsor: Chimei Medical Center
Sponsor class: OTHER
First posted: 2019-07-25
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ARDS patients prospectively through screening patients with bilateral radiographic infiltrates and a PaO2/FiO2 ratio of 200 mmHg or less by respiratory therapist.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: mortality
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Department of Intensive Care Medicine; Chi Mei Medical Center
Study officials:
affiliation: Chi Mei Medical Hospital
name: Kuo-Chen Cheng, Chief
role: STUDY_CHAIR
References: