MortalityNCT04032288
Establish a Prospective Registration System of ARDS Patients for Improving Quality of Care
An observational study of Mortality, run by Chimei Medical Center at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Mortality
- How many people
- 180 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Oct 2012to 11 Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ARDS patients prospectively through screening patients with bilateral radiographic infiltrates and a PaO2/FiO2 ratio of 200 mmHg or less by respiratory therapist.
Who cannot join
- NA.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Intensive Care Medicine; Chi Mei Medical Center
Tainan, 710
About this study
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.
Read the 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.
- Conditions
- Mortality
- Keywords
- ARDS, Low tidal volume ventilation, Outcomes
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Hospital Mortality Rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start11 Oct 2012
- Primary completionJul 2015
- Study completion11 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MortalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chimei Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuo-Chen Cheng, Chimei Medical Center
- Investigators
- Kuo-Chen Cheng, Chief, Study chair, Chi Mei Medical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032288
- Sponsor's protocol ID
- CMFHR10154(IRB10110-009)
- Status last verified
- Jul 2019
- First submitted
- 24 Jan 2018
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establish a Prospective Registration System of ARDS Patients for Improving Quality of Care
- ClinicalTrials.gov ID
- NCT04032288
- Acronym / sponsor ID
- CMFHR10154(IRB10110-009)
- Conditions
- Mortality
- Keywords
- ARDS, Low tidal volume ventilation, Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Chimei Medical CenterUniversity, hospital or other
- Study start
- 11 Oct 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- 11 Aug 2016 (actual)
- First posted
- 25 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- ARDS patients prospectively through screening patients with bilateral radiographic infiltrates and a PaO2/FiO2 ratio of 200 mmHg or less by respiratory therapist.
Key exclusion criteria (1 listed)
- NA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mortality
Time frame: 1 year
Hospital Mortality Rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuo-Chen Cheng, Chief study chair
Chi Mei Medical Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mortality, run by Chimei Medical Center at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2019.