Clinical trial NCT02517073: Practice of Mechanical Ventilation in Patients With Severe Brain Injury in China
Official title: A Survey on the Practice of Mechanical Ventilation Among Patients With Severe Brain Injury in China: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiration, Artificial
Keywords: mechanical ventilation
epidemiology
intensive care unit
national survey
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2015-08-06
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mechanical ventilated patients with severe brain injury

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. older than 18 years
2. 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)
3. mechanical ventilated for at least 24 hours before the time of on-spot survey

Exclusion Criteria:

1. undergoing a spontaneous breathing trial (SBT) at the time of on-spot survey
2. underwent at least once SBT in the preceding 24 hours before time of on-spot survey
3. enrolled in another trial

Primary outcomes:
measure: Number of patients receiving control and assist mode of mechanical ventilation
timeFrame: During 1 hour of on-spot survey
Secondary outcomes:
measure: The settings of tidal volume, inspiratory pressure, and positive end-expiratory pressure in enrolled patients
timeFrame: During 1 hour of on-spot survey
measure: Duration of mechanical ventilation
timeFrame: 60 days after on-spot survey
measure: Number of patients liberated from mechanical ventilation
timeFrame: 60 days after on-spot survey
measure: Neurological outcome by Glasgow Outcome Scale
timeFrame: 60 days after on-spot survey
Other outcomes:
Locations:
city: Beijing
country: China
facility: ICU, Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Acute Brain Injury and Critical Care Research Collaboration, ABC Research Collaboration
name: Jian-Xin Zhou, MD
role: STUDY_CHAIR
References:
citation: 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.