ARDSNCT04215666
Diagnostic Criteria of ARDS at High Altitudes in Western China
An observational study of ARDS, run by Affiliated Hospital of Qinghai University at 1 site in China.
Trial summary
The severity of ARDS in high altitude areas was classified according to the Berlin standard high altitude area Oxygenation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 31 Dec 2022
- 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 2019 to 2022, patients diagnosed with ARDS were admitted to the department of critical care medicine of qinghai university affiliated hospital, qinghai provincial people's hospital and other selected units
Who may be able to join
- age ≥18
- the primary disease of ARDS caused by systemic infection, shock, severe pneumonia, aspiration and trauma
- blood gas analysis showed a progressive decline in pulmonary ventilation function
- PEEP≥5cmH2O Exclusion criteria
- Receive a large amount of hormone shock therapy in a short period of time
- Died within a short time (< 24h) after mechanical ventilation
- Lack of data
- No chest imaging data
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated hospital of qinghai university
Xining, Qinghai, 810000
Gan Guifen, Bachelor, 15897083336, xzhd1991@163.com
About this study
The severity of ARDS in high altitude areas was classified according to the Berlin standard high altitude area Oxygenation.
Read the detailed description
Will between January 2018 and December 2018 in lanzhou, and so on more than 1500 meters above sea level in qinghai region 10 intensive care patients with ARDS, respectively according to the standard in Berlin, Berlin, diagnosis of high altitude ARDS calibration standards and zhang the plateau region in western China put forward by the diagnosis of ALI/ARDS severity classification, observation group patients were ICU mortality, within 28 days, ICU mortality did not use breathing machine time, mechanical ventilation, ICU length of hospital stay, and the differences in hospitalization days.
- Conditions
- ARDS
- Keywords
- ARDS, Definitions, 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 | Oxygenation standards were calculated based on the Berlin diagnostic high element correction formula combined with local atmospheric pressure | |
| Moderate ARDS | Oxygenation standards were calculated based on the Berlin diagnostic high element correction formula combined with local atmospheric pressure | |
| Severe ARDS | Oxygenation standards were calculated based on the Berlin diagnostic high element correction formula combined with local atmospheric pressure |
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
mortality at 28 days of hospitalization
Measured: up to 24 weeks
Secondary outcomes (2)
Ventilator Free time
No ventilator use time in ICU
Measured: up to 24 weeks
Ventilator time
Ventilator time in ICU
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 posted2 Jan 2020
- Study start1 Dec 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 3,000 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Qinghai University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Fudan University
- Responsible party
- Principal investigator, Guifen Gan, Affiliated Hospital of Qinghai University
- Investigators
- Gan Guifen, Bachelor, Principal investigator, Affiliated Hospital of Qinghai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215666
- Sponsor's protocol ID
- ARDS Criteria high altitudes
- Status last verified
- Dec 2019
- First submitted
- 30 Dec 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Criteria of ARDS at High Altitudes in Western China
- ClinicalTrials.gov ID
- NCT04215666
- Acronym / sponsor ID
- ARDS Criteria high altitudes
- Conditions
- ARDS
- Keywords
- ARDS, Definitions, high-altitude
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Qinghai UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital of Fudan University
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 2 Jan 2020 (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 of ARDS in high altitude areas was classified according to the Berlin standard high altitude area Oxygenation.
Detailed description
Will between January 2018 and December 2018 in lanzhou, and so on more than 1500 meters above sea level in qinghai region 10 intensive care patients with ARDS, respectively according to the standard in Berlin, Berlin, diagnosis of high altitude ARDS calibration standards and zhang the plateau region in western China put forward by the diagnosis of ALI/ARDS severity classification, observation group patients were ICU mortality, within 28 days, ICU mortality did not use breathing machine time, mechanical ventilation, ICU length of hospital stay, and the differences in 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 | – | –Oxygenation standards were calculated based on the Berlin diagnostic high element correction formula combined with local atmospheric pressure |
| Moderate ARDS | – | –Oxygenation standards were calculated based on the Berlin diagnostic high element correction formula combined with local atmospheric pressure |
| Severe ARDS | – | –Oxygenation standards were calculated based on the Berlin diagnostic high element correction formula combined with local atmospheric pressure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From 2019 to 2022, patients diagnosed with ARDS were admitted to the department of critical care medicine of qinghai university affiliated hospital, qinghai provincial people's hospital and other selected units
Key inclusion criteria (8 listed)
- age ≥18
- the primary disease of ARDS caused by systemic infection, shock, severe pneumonia, aspiration and trauma
- blood gas analysis showed a progressive decline in pulmonary ventilation function
- PEEP≥5cmH2O Exclusion criteria
- Receive a large amount of hormone shock therapy in a short period of time
Key exclusion criteria (0 listed)
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
Time frame: up to 24 weeks
mortality at 28 days of hospitalization
2 secondary outcomes
Ventilator Free time
Time frame: up to 24 weeks
Ventilator time
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 2 Jan 2020.
Related trials for ARDS
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
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.
Gan Guifen, 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, run by Affiliated Hospital of Qinghai University 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 8 inclusion and 0 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 2 Jan 2020. 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?
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 2 Jan 2020.