NCT03212482

Brief Summary

Mechanical ventilation is an important support strategy for critically ill patients. It could improve gas exchange, reduce the work of breathing, and improve patient comfort. However, patient-ventilator asynchrony, which defined as a mismatch between the patient and ventilator may obfuscate these goals. Studies have shown that a high incidence of asynchrony (asynchrony index \> 10%) is associated with prolonged mechanical ventilation and ICU length of stay and high mortality. So far, there have been only a few studies on the epidemiology of asynchrony in brain-injured patients. Investigators conduct a prospective observational study among brain-injured patients to determine the prevalence, risk factors and outcomes of patient-ventilator asynchrony. Esophageal pressure monitoring, a surrogate for pleural pressure, combined with airway pressure and flow waveforms is used to detect patient-ventilator asynchrony.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2017

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 4, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2020

Completed
Last Updated

May 29, 2020

Status Verified

May 1, 2020

Enrollment Period

2 years

First QC Date

July 4, 2017

Last Update Submit

May 28, 2020

Conditions

Keywords

brain-injured patients, patient-ventilator asychrony

Outcome Measures

Primary Outcomes (1)

  • The incidence of patient-ventilator asynchrony in brain-injured patients

    The incidence of different types of patient-ventilator asynchrony in brain-injured patients.

    Three days

Secondary Outcomes (1)

  • The risk factors of patient-ventilator asynchrony in brain-injured patients

    Three days

Eligibility Criteria

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

Adult patients with brain injury and receiving MV for at least 72 hours in the intensive care unit, will be enrolled in the study.

You may qualify if:

  • \) \]older than 18 years 2) with brain injury in the ICU 3) mechanical ventilated for at least 72 hours

You may not qualify if:

  • \) ICU length of stay less than 24 hours 2) enrolled in another trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jian-Xin Zhou

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (1)

  • Luo XY, He X, Zhou YM, Wang YM, Chen JR, Chen GQ, Li HL, Yang YL, Zhang L, Zhou JX. Patient-ventilator asynchrony in acute brain-injured patients: a prospective observational study. Ann Intensive Care. 2020 Oct 19;10(1):144. doi: 10.1186/s13613-020-00763-8.

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

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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctoral Student Supervisor, chief of the department and Deputy Dean of the hospital

Study Record Dates

First Submitted

July 4, 2017

First Posted

July 11, 2017

Study Start

June 15, 2017

Primary Completion

July 1, 2019

Study Completion

February 29, 2020

Last Updated

May 29, 2020

Record last verified: 2020-05

Locations