NCT02863237

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

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2016

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

June 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

August 1, 2016

Last Update Submit

January 21, 2020

Conditions

Keywords

brain injurymechanical ventilationweaning

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

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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.

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Jian-Xin Zhou, MD

    Beijing Tiantan Hospital

    STUDY CHAIR

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

Locations