ARDSNCT04199650
Definition of ARDS in Qinghai Province: Verification of Berlin Definition Plateau Criteria
An observational study of ARDS and High Altitude, run by Southeast University, China at 1 site in China.
Trial summary
The severity stratification criteria for acute respiratory distress syndrome (ARDS) in Xi'ning Qinghai province (mean altitude: 2200m) were clarified according to the oxygenation index (PaO2/FiO2). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, High Altitude
- How many people
- 253 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 30 Aug 2020
- How long will I take part?
- 1 Month
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From January 2018 to December 2018, patients admitted to the department of critical care, affiliated hospital of qinghai university were diagnosed with acute respiratory distress syndrome according to Berlin Definition.
Who may be able to join
- 18 years of age
- Meet the diagnostic criteria of ARDS
- Receive invasive mechanical ventilation
Who cannot join
- Receive a large number of hormone shock therapy in a short period of time
- Death within a short period of time (< 24 h) after mechanical ventilation
- No chest imaging data
- Data missing
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
ChunPan
Nanjing, Jiangsu, 210000
Guifen Gan, Bachelor, 15897083336, xzhd1991@163.com
Xiaoqin Liu, Bachelor, 17809821708, liuxq0411@163.com
About this study
Official title: Definition of Acute Respiratory Distress Syndrome in Plateau of Qinghai in China: Verification of Berlin Definition Plateau Criteria
The severity stratification criteria for acute respiratory distress syndrome (ARDS) in Xi'ning Qinghai province (mean altitude: 2200m) were clarified according to the oxygenation index (PaO2/FiO2).
Read the detailed description
This study is a single-center retrospective study. According to the Berlin diagnostic standard, ARDS patients admitted to the Department of severe Medicine, affiliated Hospital of Qinghai University from January 2018 to December 2018 were divided into three groups: mild (153mmHg < PaO2/ FiO2 ≥ 230 mmHg), moderate (76mmHg < PaO2/ FiO2 ≥ 153 mmHg) and severe (PaO2/ FiO2 ≥ 76 mmHg). The ICU mortality, 28-day mortality, non-ventilator time in ICU, ICU hospitalization time and non-I hospitalization were observed respectively. The difference of CU time and total hospitalization days.
- Conditions
- ARDS, High Altitude
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mild ARDS | 153mmHg<PaO2/FiO2≤230mmHg | |
| Moderate ARDS | 76mmHg<PaO2/FiO2≤153mmHg | |
| Severe ARDS | PaO2/FiO2≤76mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU mortality
Mortality during treatment in ICU
Measured: up to 24 weeks
28-days mortality rate
Mortality at 28 days of hospitalization
Measured: 28 days after discharge
Secondary outcomes (3)
Ventilator Free time
Ventilator time not used in ICU
Measured: up to 24 weeks
Ventilator time
Ventilator time in ICU
Measured: up to 24 weeks
Hospital length of stay
Total length of stay in hospital
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start1 Apr 2019
- Primary completion30 Jan 2020 (estimated)
- Study completion30 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ARDSStudies 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
- Case only
- Time perspective
- Other
- Enrolment
- 253 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Hospital of Qinghai University
- Responsible party
- Principal investigator, Chun Pan, Southeast University, China
- Investigators
- Liu Xiaoqin, Bachelor, Principal investigator, Affiliated Hospital of Qinghai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199650
- Sponsor's protocol ID
- ARDS Plateau Criteria
- Status last verified
- Dec 2019
- First submitted
- 5 Dec 2019
- Last updated
- 16 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu X, Pan C, Si L, Tong S, Niu Y, Qiu H, Gan G. Definition of Acute Respiratory Distress Syndrome on the Plateau of Xining, Qinghai: A Verification of the Berlin Definition Altitude-PaO2/FiO2-Corrected Criteria. Front Med (Lausanne). 2022 Feb 23;9:648835. doi: 10.3389/fmed.2022.648835. eCollection 2022.
PubMed 35280910
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Definition of Acute Respiratory Distress Syndrome in Plateau of Qinghai in China: Verification of Berlin Definition Plateau Criteria
- ClinicalTrials.gov ID
- NCT04199650
- Acronym / sponsor ID
- ARDS Plateau Criteria
- Conditions
- ARDS, High Altitude
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 253 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Collaborators
- Affiliated Hospital of Qinghai University
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Jan 2020 (estimated)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 16 Dec 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 severity stratification criteria for acute respiratory distress syndrome (ARDS) in Xi'ning Qinghai province (mean altitude: 2200m) were clarified according to the oxygenation index (PaO2/FiO2).
Detailed description
This study is a single-center retrospective study. According to the Berlin diagnostic standard, ARDS patients admitted to the Department of severe Medicine, affiliated Hospital of Qinghai University from January 2018 to December 2018 were divided into three groups: mild (153mmHg < PaO2/ FiO2 ≥ 230 mmHg), moderate (76mmHg < PaO2/ FiO2 ≥ 153 mmHg) and severe (PaO2/ FiO2 ≥ 76 mmHg). The ICU mortality, 28-day mortality, non-ventilator time in ICU, ICU hospitalization time and non-I hospitalization were observed respectively. The difference of CU time and total hospitalization days.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 1 Month
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild ARDS | – | –153mmHg<PaO2/FiO2≤230mmHg |
| Moderate ARDS | – | –76mmHg<PaO2/FiO2≤153mmHg |
| Severe ARDS | – | –PaO2/FiO2≤76mmHg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From January 2018 to December 2018, patients admitted to the department of critical care, affiliated hospital of qinghai university were diagnosed with acute respiratory distress syndrome according to Berlin Definition.
Key inclusion criteria (3 listed)
- 18 years of age
- Meet the diagnostic criteria of ARDS
- Receive invasive mechanical ventilation
Key exclusion criteria (4 listed)
- Receive a large number of hormone shock therapy in a short period of time
- Death within a short period of time (< 24 h) after mechanical ventilation
- No chest imaging data
- Data missing
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
ICU mortality
Time frame: up to 24 weeks
Mortality during treatment in ICU
28-days mortality rate
Time frame: 28 days after discharge
Mortality at 28 days of hospitalization
3 secondary outcomes
Ventilator Free time
Time frame: up to 24 weeks
Ventilator time
Time frame: up to 24 weeks
Hospital length of stay
Time frame: up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Derived from this study: PubMed 35280910Liu X, Pan C, Si L, Tong S, Niu Y, Qiu H, Gan G. Definition of Acute Respiratory Distress Syndrome on the Plateau of Xining, Qinghai: A Verification of the Berlin Definition Altitude-PaO2/FiO2-Corrected Criteria. Front Med (Lausanne). 2022 Feb 23;9:648835. doi: 10.3389/fmed.2022.648835. eCollection 2022.
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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.
Liu Xiaoqin, Bachelor principal investigator
Affiliated Hospital of Qinghai University
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 ARDS and High Altitude, run by Southeast University, China at 1 site in China.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 16 Dec 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gan Guifen, Bachelor (15897083336, xzhd1991@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU mortality (time frame: up to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04199650, which also lists 1 linked publication.
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 16 Dec 2019.