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Practice of Mechanical Ventilation in Patients With Severe Brain Injury in China

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02517073
First Posted: August 6, 2015
Last Update Posted: January 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jian-Xin Zhou, Capital Medical University
  Purpose
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.

Condition
Respiration, Artificial

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: A Survey on the Practice of Mechanical Ventilation Among Patients With Severe Brain Injury in China: a Prospective Observational Study

Further study details as provided by Jian-Xin Zhou, Capital Medical University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 104
Study Start Date: August 2015
Study Completion Date: September 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Mechanical ventilated patients with severe brain injury
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02517073


Locations
China, Beijing
ICU, Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing, China, 100050
Sponsors and Collaborators
Capital Medical University
Investigators
Study Chair: Jian-Xin Zhou, MD Acute Brain Injury and Critical Care Research Collaboration, ABC Research Collaboration
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jian-Xin Zhou, Professor, Capital Medical University
ClinicalTrials.gov Identifier: NCT02517073     History of Changes
Other Study ID Numbers: MCS-2015-008
First Submitted: August 4, 2015
First Posted: August 6, 2015
Last Update Posted: January 28, 2016
Last Verified: January 2016

Keywords provided by Jian-Xin Zhou, Capital Medical University:
mechanical ventilation
epidemiology
intensive care unit
national survey

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries