Predictors of Weaning Outcomes for Brain Injured Patients
1 other identifier
observational
46
1 country
1
Brief Summary
Brian injured patients are predisposed to various complications related to mechanical ventilation. Appropriate decision making of the weaning is crucial and validated predictive parameters are desirable. In present study, the investigators aim to a) validate the electrical activity of diaphragm (EAdi) derived parameters, and b) evaluate the traditional predictive parameters in weaning prediction in brain injured patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 1, 2016
CompletedFirst Posted
Study publicly available on registry
August 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedJanuary 23, 2020
January 1, 2018
2 years
August 1, 2016
January 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Electrical activity of diaphragm measured at the 1, 5, 10, 20, and 30 minutes into the spontaneous breathing trail
Measurements are obtained from five consecutive breaths at at the 1, 5, 10, 20, and 30 minutes into the spontaneous breathing trail
30 minutes
Secondary Outcomes (6)
Change in Esophageal pressure
30 minutes
Change in Respiratory Rate
30 minutes
Change in Airway pressure
30 minutes
Change in Intrinsic positive end-expiratory pressure
30 minutes
Change in Esophageal pressure time product
30 minutes
- +1 more secondary outcomes
Study Arms (2)
weaning failure group
Patients reconnected to the ventilator within 48 hours after SBT will be designated the weaning failure group
weaning success group
Patients who pass the SBT and breathing without ventilator support within 48 hours are designated the weaning success group
Eligibility Criteria
Brain injured patients receiving mechanical ventilation
You may qualify if:
- Age between 18 to 80 years
- Mechanical ventilation \> 24 hours
- Fulfilling the weaning screen criteria
You may not qualify if:
- Moribund or brain dead
- With spinal injury
- Status epilepsy
- Contraindication to EAdi catheter placement
- Severe cardiac disease
- Company with chest or abdominal injury
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ICU, Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Related Publications (1)
Shi ZH, Jonkman AH, Tuinman PR, Chen GQ, Xu M, Yang YL, Heunks LMA, Zhou JX. Role of a successful spontaneous breathing trial in ventilator liberation in brain-injured patients. Ann Transl Med. 2021 Apr;9(7):548. doi: 10.21037/atm-20-6407.
PMID: 33987246DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jian-Xin Zhou, MD
Beijing Tiantan Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 1, 2016
First Posted
August 11, 2016
Study Start
June 1, 2016
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
January 23, 2020
Record last verified: 2018-01