NCT02517073

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2015

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

Same day

First QC Date

August 4, 2015

Last Update Submit

January 26, 2016

Conditions

Keywords

mechanical ventilationepidemiologyintensive care unitnational survey

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    During 1 hour of on-spot survey

  • Duration of mechanical ventilation

    60 days after on-spot survey

  • Number of patients liberated from mechanical ventilation

    60 days after on-spot survey

  • Neurological outcome by Glasgow Outcome Scale

    60 days after on-spot survey

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Mechanical ventilated patients with severe brain injury

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICU, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jian-Xin Zhou, MD

    Acute Brain Injury and Critical Care Research Collaboration, ABC Research Collaboration

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 4, 2015

First Posted

August 6, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2015

Study Completion

September 1, 2015

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations