Respiration, ArtificialNCT02517073
Practice of Mechanical Ventilation in Patients With Severe Brain Injury in China
An observational study of Respiration, Artificial, run by Capital Medical University at 1 site in China.
Trial summary
The mechanical ventilation strategy has changed over years worldwide. Several international researches have been conducted to study the association of the use of mechanical ventilation with clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiration, Artificial
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- Aug 2015to Sep 2015
- 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: Mechanical ventilated patients with severe brain injury
Who may be able to join
- older than 18 years
- with severe brain injury (including severe traumatic brain injury, ischemic stroke, subarachnoid hemorrhage, spontaneous intracerebral hemorrhage, hypoxic-ischemic encephalopathy, intracranial tumor, intracranial infection and idiopathic epilepsy)
- mechanical ventilated for at least 24 hours before the time of on-spot survey
Who cannot join
- undergoing a spontaneous breathing trial (SBT) at the time of on-spot survey
- underwent at least once SBT in the preceding 24 hours before time of on-spot survey
- enrolled in another trial
Trial locations and contacts
1 site in 1 country.
China1 site
ICU, Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
About this study
Official title: A Survey on the Practice of Mechanical Ventilation Among Patients With Severe Brain Injury in China: a Prospective Observational Study
The mechanical ventilation strategy has changed over years worldwide. Several international researches have been conducted to study the association of the use of mechanical ventilation with clinical outcomes. In this prospective, multicenter, cross-sectional survey, the practice of mechanical ventilation among patients with severe brain injury will be investigated in 70 intensive care units in China.
- Conditions
- Respiration, Artificial
- Keywords
- mechanical ventilation, epidemiology, intensive care unit, national survey
- Medical subject headings
- Respiratory Aspiration
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients receiving control and assist mode of mechanical ventilation
Control mode is defined as volume or pressure control ventilation. Assist mode is defined as synchronized intermittent mandatory ventilation and pressure support ventilation.
Measured: During 1 hour of on-spot survey
Secondary outcomes (4)
The settings of tidal volume, inspiratory pressure, and positive end-expiratory pressure in enrolled patients
Measured: During 1 hour of on-spot survey
Duration of mechanical ventilation
Measured: 60 days after on-spot survey
Number of patients liberated from mechanical ventilation
Measured: 60 days after on-spot survey
Neurological outcome by Glasgow Outcome Scale
Measured: 60 days after on-spot survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2015
- Study completionSep 2015
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 Respiration, ArtificialStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Xin Zhou, Capital Medical University
- Investigators
- Jian-Xin Zhou, MD, Study chair, Acute Brain Injury and Critical Care Research Collaboration, ABC Research Collaboration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517073
- Sponsor's protocol ID
- MCS-2015-008
- Status last verified
- Jan 2016
- First submitted
- 4 Aug 2015
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Luo XY, Hu YH, Cao XY, Kang Y, Liu LP, Wang SH, Yu RG, Yu XY, Zhang X, Li BS, Ma ZX, Weng YB, Zhang H, Chen DC, Chen W, Chen WJ, Chen XM, Du B, Duan ML, Hu J, Huang YF, Jia GJ, Li LH, Liang YM, Qin BY, Wang XD, Xiong J, Yan LM, Yang ZP, Dong CM, Wang DX, Zhan QY, Fu SL, Zhao L, Huang QB, Xie YG, Huang XB, Zhang GB, Xu WB, Xu Y, Liu YL, Zhao HL, Sun RQ, Sun M, Cheng QH, Qu X, Yang XF, Xu M, Shi ZH, Chen H, He X, Yang YL, Chen GQ, Sun XM, Zhou JX; Acute Brain Injury and Critical Care Research Collaboration (ABC Research Collaboration). Lung-protective Ventilation in Patients with Brain Injury: A Multicenter Cross-sectional Study and Questionnaire Survey in China. Chin Med J (Engl). 2016 Jul 20;129(14):1643-51. doi: 10.4103/0366-6999.185869.
PubMed 27411450
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Survey on the Practice of Mechanical Ventilation Among Patients With Severe Brain Injury in China: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02517073
- Acronym / sponsor ID
- MCS-2015-008
- Conditions
- Respiration, Artificial
- Keywords
- mechanical ventilation, epidemiology, intensive care unit, national survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 6 Aug 2015 (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 mechanical ventilation strategy has changed over years worldwide. Several international researches have been conducted to study the association of the use of mechanical ventilation with clinical outcomes. In this prospective, multicenter, cross-sectional survey, the practice of mechanical ventilation among patients with severe brain injury will be investigated in 70 intensive care units in China.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanical ventilated patients with severe brain injury
Key inclusion criteria (3 listed)
- older than 18 years
- with severe brain injury (including severe traumatic brain injury, ischemic stroke, subarachnoid hemorrhage, spontaneous intracerebral hemorrhage, hypoxic-ischemic encephalopathy, intracranial tumor, intracranial infection and idiopathic epilepsy)
- mechanical ventilated for at least 24 hours before the time of on-spot survey
Key exclusion criteria (3 listed)
- undergoing a spontaneous breathing trial (SBT) at the time of on-spot survey
- underwent at least once SBT in the preceding 24 hours before time of on-spot survey
- enrolled in another trial
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
Number of patients receiving control and assist mode of mechanical ventilation
Time frame: During 1 hour of on-spot survey
Control mode is defined as volume or pressure control ventilation. Assist mode is defined as synchronized intermittent mandatory ventilation and pressure support ventilation.
4 secondary outcomes
The settings of tidal volume, inspiratory pressure, and positive end-expiratory pressure in enrolled patients
Time frame: During 1 hour of on-spot survey
Duration of mechanical ventilation
Time frame: 60 days after on-spot survey
Number of patients liberated from mechanical ventilation
Time frame: 60 days after on-spot survey
Neurological outcome by Glasgow Outcome Scale
Time frame: 60 days after on-spot survey
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 28 Jan 2016.
- Derived from this study: PubMed 27411450Luo XY, Hu YH, Cao XY, Kang Y, Liu LP, Wang SH, Yu RG, Yu XY, Zhang X, Li BS, Ma ZX, Weng YB, Zhang H, Chen DC, Chen W, Chen WJ, Chen XM, Du B, Duan ML, Hu J, Huang YF, Jia GJ, Li LH, Liang YM, Qin BY, Wang XD, Xiong J, Yan LM, Yang ZP, Dong CM, Wang DX, Zhan QY, Fu SL, Zhao L, Huang QB, Xie YG, Huang XB, Zhang GB, Xu WB, Xu Y, Liu YL, Zhao HL, Sun RQ, Sun M, Cheng QH, Qu X, Yang XF, Xu M, Shi ZH, Chen H, He X, Yang YL, Chen GQ, Sun XM, Zhou JX; Acute Brain Injury and Critical Care Research Collaboration (ABC Research Collaboration). Lung-protective Ventilation in Patients with Brain Injury: A Multicenter Cross-sectional Study and Questionnaire Survey in China. Chin Med J (Engl). 2016 Jul 20;129(14):1643-51. doi: 10.4103/0366-6999.185869.
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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.
Jian-Xin Zhou, MD study chair
Acute Brain Injury and Critical Care Research Collaboration, ABC Research Collaboration
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 Respiration, Artificial, run by Capital Medical 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 3 inclusion and 3 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 28 Jan 2016. 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?
Number of patients receiving control and assist mode of mechanical ventilation (time frame: During 1 hour of on-spot survey). 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 NCT02517073, 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 28 Jan 2016.