Patient-ventilator Asynchrony in Patients With Brain Injury

May 28, 2020 updated by: Jian-Xin Zhou
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Jian-Xin Zhou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of patient-ventilator asynchrony in brain-injured patients
Time Frame: Three days
The incidence of different types of patient-ventilator asynchrony in brain-injured patients.
Three days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The risk factors of patient-ventilator asynchrony in brain-injured patients
Time Frame: Three days
The risk factors of different types of patient-ventilator asynchrony in brain-injured patients
Three days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jian-Xin Zhou

Investigators

  • Study Chair: Jian-Xin Zhou, MD, Acute Brain Injury and Critical Care Research Collaboration, ABC Research Collaboration

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2017

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

February 29, 2020

Study Registration Dates

First Submitted

July 4, 2017

First Submitted That Met QC Criteria

July 7, 2017

First Posted (Actual)

July 11, 2017

Study Record Updates

Last Update Posted (Actual)

May 29, 2020

Last Update Submitted That Met QC Criteria

May 28, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY 2017-028-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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