Respiratory FailureNCT01666834
Cross-section Survey of Mechanical Ventilation and Acute Respiratory Distress Syndrome in China
An observational study of Respiratory Failure and Acute Respiratory Distress Syndrome, run by Southeast University, China at 1 site in China.
Trial summary
The characteristics and outcomes of a mixed group of critically ill patients who received mechanical ventilation are not known in China. A 1 month Cross-section survey will be performed with the aim of describing the characteristics and outcomes of conventional mechanical ventilation and treatment of acute respiratory… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Respiratory Failure, Acute Respiratory Distress Syndrome
- How many people
- 555 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to May 2013
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A mixed group of critically ill patients who received mechanical ventilation or patient with ARDS
Who may be able to join
- Meet one of the following criteria
- Patients who were admitted to ICU from September 1st to 31th 2012, and received invasive mechanical ventilation for more than 24 hours
- Patients who were admitted to ICU from September 1st to 31th 2012, and received non-invasive mechanical ventilation for more than 12 hours
- Patients who were admitted to ICU from September 1st to 31th 2012, and who fulifll the ARDS Berlin Definition or AECC Definiton
Who cannot join
- 1. lesson than 18 years old or more than 85 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Southeast Univerity
The characteristics and outcomes of a mixed group of critically ill patients who received mechanical ventilation are not known in China.
A 1 month Cross-section survey will be performed with the aim of describing the characteristics and outcomes of conventional mechanical ventilation and treatment of acute respiratory distress syndrome in intensive care units in China.
Read the detailed description
From August 31th 2012 to September 30th 2012, all patients admit to ICUs were screened, mechanical patients and patients with ARDS be enrolled. The demographic characteristics, diagnosis, formerly medical history, Ventilator indications, Ventilator data, other respiratory treatments, weaning outcome and 28 day mortality, and the treatment of ARDS will be recorded.
- Keywords
- mechanical ventilation, ARDS, Ventilator strategy, outcome
- Medical subject headings
- Respiratory Insufficiency, Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
percentange of mechanical ventilation
in the onw month period, How many patients in the intensive care unit are ventilated.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies 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
- Cross-sectional
- Enrolment
- 555 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
- Investigators
- Haibo Qiu, professor, Study director, southeast university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666834
- Sponsor's protocol ID
- zdyyicu3
- Status last verified
- May 2013
- First submitted
- 14 Aug 2012
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Xie J, Liu L, Yang Y, Yu W, Li M, Yu K, Zheng R, Yan J, Wang X, Cai G, Li J, Gu Q, Zhao H, Mu X, Ma X, Qiu H. A modified acute respiratory distress syndrome prediction score: a multicenter cohort study in China. J Thorac Dis. 2018 Oct;10(10):5764-5773. doi: 10.21037/jtd.2018.09.117.
PubMed 30505484Liu L, Yang Y, Gao Z, Li M, Mu X, Ma X, Li G, Sun W, Wang X, Gu Q, Zheng R, Zhao H, Ao D, Yu W, Wang Y, Chen K, Yan J, Li J, Cai G, Wang Y, Wang H, Kang Y, Slutsky AS, Liu S, Xie J, Qiu H. Practice of diagnosis and management of acute respiratory distress syndrome in mainland China: a cross-sectional study. J Thorac Dis. 2018 Sep;10(9):5394-5404. doi: 10.21037/jtd.2018.08.137.
PubMed 30416787
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Southeast Univerity
- ClinicalTrials.gov ID
- NCT01666834
- Acronym / sponsor ID
- zdyyicu3
- Keywords
- mechanical ventilation, ARDS, Ventilator strategy, outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 555 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital
- Study start
- Jul 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 16 Aug 2012 (estimated)
- 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 characteristics and outcomes of a mixed group of critically ill patients who received mechanical ventilation are not known in China.
A 1 month Cross-section survey will be performed with the aim of describing the characteristics and outcomes of conventional mechanical ventilation and treatment of acute respiratory distress syndrome in intensive care units in China.
Detailed description
From August 31th 2012 to September 30th 2012, all patients admit to ICUs were screened, mechanical patients and patients with ARDS be enrolled. The demographic characteristics, diagnosis, formerly medical history, Ventilator indications, Ventilator data, other respiratory treatments, weaning outcome and 28 day mortality, and the treatment of ARDS will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A mixed group of critically ill patients who received mechanical ventilation or patient with ARDS
Key inclusion criteria (4 listed)
- Meet one of the following criteria
- Patients who were admitted to ICU from September 1st to 31th 2012, and received invasive mechanical ventilation for more than 24 hours
- Patients who were admitted to ICU from September 1st to 31th 2012, and received non-invasive mechanical ventilation for more than 12 hours
- Patients who were admitted to ICU from September 1st to 31th 2012, and who fulifll the ARDS Berlin Definition or AECC Definiton
Key exclusion criteria (1 listed)
- 1. lesson than 18 years old or more than 85 years old
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
percentange of mechanical ventilation
Time frame: 1 month
in the onw month period, How many patients in the intensive care unit are ventilated.
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 4 Jan 2017.
- Derived from this study: PubMed 30505484Xie J, Liu L, Yang Y, Yu W, Li M, Yu K, Zheng R, Yan J, Wang X, Cai G, Li J, Gu Q, Zhao H, Mu X, Ma X, Qiu H. A modified acute respiratory distress syndrome prediction score: a multicenter cohort study in China. J Thorac Dis. 2018 Oct;10(10):5764-5773. doi: 10.21037/jtd.2018.09.117.
- Derived from this study: PubMed 30416787Liu L, Yang Y, Gao Z, Li M, Mu X, Ma X, Li G, Sun W, Wang X, Gu Q, Zheng R, Zhao H, Ao D, Yu W, Wang Y, Chen K, Yan J, Li J, Cai G, Wang Y, Wang H, Kang Y, Slutsky AS, Liu S, Xie J, Qiu H. Practice of diagnosis and management of acute respiratory distress syndrome in mainland China: a cross-sectional study. J Thorac Dis. 2018 Sep;10(9):5394-5404. doi: 10.21037/jtd.2018.08.137.
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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.
Haibo Qiu, professor study director
southeast 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 Respiratory Failure and Acute Respiratory Distress Syndrome, 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 4 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 4 Jan 2017. 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?
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?
percentange of mechanical ventilation (time frame: 1 month). 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 NCT01666834, which also lists 2 linked publications.
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 4 Jan 2017.