Brain InjuriesNCT03212482
Patient-ventilator Asynchrony in Patients With Brain Injury
An observational study of Brain Injuries and Mechanical Ventilation, run by Jian-Xin Zhou at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries, Mechanical Ventilation
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2017to 29 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 1) ]older than 18 years 2) with brain injury in the ICU 3) mechanical ventilated for at least 72 hours
Who cannot join
- 1) ICU length of stay less than 24 hours 2) enrolled in another trial
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Brain Injuries, Mechanical Ventilation
- Keywords
- brain-injured patients, patient-ventilator asychrony
- Medical subject headings
- Brain Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of patient-ventilator asynchrony in brain-injured patients
The incidence of different types of patient-ventilator asynchrony in brain-injured patients.
Measured: Three days
Secondary outcomes (1)
The risk factors of patient-ventilator asynchrony in brain-injured patients
The risk factors of different types of patient-ventilator asynchrony in brain-injured patients
Measured: Three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start15 Jun 2017
- Primary completion1 Jul 2019
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jian-Xin Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jian-Xin Zhou, Capital Medical University
- Investigators
- Jian-Xin Zhou, MD, Study chair, Acute Brain Injury and Critical Care Research Collaboration, ABC Research Collaboration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212482
- Sponsor's protocol ID
- KY 2017-028-02
- Status last verified
- May 2020
- First submitted
- 4 Jul 2017
- Last updated
- 29 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33074406
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-ventilator Asynchrony in Patients With Brain Injury
- ClinicalTrials.gov ID
- NCT03212482
- Acronym / sponsor ID
- KY 2017-028-02
- Conditions
- Brain Injuries, Mechanical Ventilation
- Keywords
- brain-injured patients, patient-ventilator asychrony
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jian-Xin ZhouUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 1) ]older than 18 years 2) with brain injury in the ICU 3) mechanical ventilated for at least 72 hours
Key exclusion criteria (1 listed)
- 1) ICU length of stay less than 24 hours 2) enrolled in another trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
The risk factors of patient-ventilator asynchrony in brain-injured patients
Time frame: Three days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Derived from this study: PubMed 33074406Luo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian-Xin Zhou, MD study chair
Acute Brain Injury and Critical Care Research Collaboration, ABC Research Collaboration
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries and Mechanical Ventilation, run by Jian-Xin Zhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of patient-ventilator asynchrony in brain-injured patients (time frame: Three days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03212482, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2020.