Patients Requiring Endotracheal Intubation and Invasive Mechanical VentilationNCT02981589
Weaning Outcome From Invasive Mechanical Ventilation
An observational study of Patients Requiring Endotracheal Intubation and Invasive Mechanical Ventilation, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
The main purpose of the present study was to explore the weaning failure rate from invasive mechanical ventilation and to identify risk factors of weaning failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Requiring Endotracheal Intubation and Invasive Mechanical Ventilation
- What is being tested?
- Invasive mechanical ventilation
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jul 2013to 31 Mar 2024
- 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: Patients requiring endotracheal intubation and invasive mechanical ventilation
Who may be able to join
- Requiring endotracheal intubation and invasive mechanical ventilation
Who cannot join
- Duration of invasive mechanical ventilation < 48 hours；
- Presence of tracheostomy；
- Presence of upper airway obstruction.
Trial locations and contacts
1 site in 1 country.
Zujin Luo, MD contact
China1 site, 1 recruiting
- Recruiting
Respiratory intensive care unit, Beijing Chao Yang Hospital Jingxi Campus
Beiling
Zujin Luo, MD, xmjg2002@163.com
About this study
Official title: Weaning Outcome From Invasive Mechanical Ventilation: a Prospective, Observational Cohort Study
The main purpose of the present study was to explore the weaning failure rate from invasive mechanical ventilation and to identify risk factors of weaning failure.
- Being tested
- Invasive mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive mechanical ventilationDevice
Invasive ventilation was performed to all eligible patients. When patients met predefined criteria, spontaneous breathing trial was performed. Given spontaneous breathing trial passed, patients were extubated; on the contrary, patients would continue to receive invasive ventilation. If patients had respiratory failure after extubation, reintubation and invasive ventilation were necessary.
What is being measured
The primary outcome is the main question the study is designed to answer.
Weaning failure rate
Measured: 3.5 years
Spontaneous breathing trial failure rate
Measured: 3.5 years
Extubation failure rate
Measured: 3.5 years
Secondary outcomes (4)
ICU mortality
Measured: 3.5 years
Hospital mortality
Measured: 3.5 years
ICU length of stay
Measured: 3.5 years
Hospital length of stay
Measured: 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startJul 2013
- Primary completionDec 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
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 Patients Requiring Endotracheal Intubation and Invasive Mechanical VentilationStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zujin Luo, Beijing Chao Yang Hospital
- Investigators
- Zujin Luo, MD, Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981589
- Sponsor's protocol ID
- BeijingCYH-ICU-003
- Status last verified
- Jun 2021
- First submitted
- 1 Dec 2016
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Luo Z, Zheng Y, Yang L, Liu S, Zhu J, Zhao N, Pang B, Cao Z, Ma Y. Neutrophil/lymphocyte ratio is helpful for predicting weaning failure: a prospective, observational cohort study. J Thorac Dis. 2018 Sep;10(9):5232-5245. doi: 10.21037/jtd.2018.08.68.
PubMed 30416770
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weaning Outcome From Invasive Mechanical Ventilation: a Prospective, Observational Cohort Study
- ClinicalTrials.gov ID
- NCT02981589
- Acronym / sponsor ID
- BeijingCYH-ICU-003
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 5 Dec 2016 (estimated)
- 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.
The main purpose of the present study was to explore the weaning failure rate from invasive mechanical ventilation and to identify risk factors of weaning failure.
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
- Patients requiring endotracheal intubation and invasive mechanical ventilation
Key inclusion criteria (1 listed)
- Requiring endotracheal intubation and invasive mechanical ventilation
Key exclusion criteria (3 listed)
- Duration of invasive mechanical ventilation < 48 hours；
- Presence of tracheostomy；
- Presence of upper airway obstruction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invasive mechanical ventilationInvasive ventilation was performed to all eligible patients. When patients met predefined criteria, spontaneous breathing trial was performed. Given spontaneous breathing trial passed, patients were extubated; on the contrary, patients would continue to receive invasive ventilation. If patients had respiratory failure after extubation, reintubation and invasive ventilation were necessary. | Device | – |
Primary outcome
Weaning failure rate
Time frame: 3.5 years
Spontaneous breathing trial failure rate
Time frame: 3.5 years
Extubation failure rate
Time frame: 3.5 years
4 secondary outcomes
ICU mortality
Time frame: 3.5 years
Hospital mortality
Time frame: 3.5 years
ICU length of stay
Time frame: 3.5 years
Hospital length of stay
Time frame: 3.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Derived from this study: PubMed 30416770Luo Z, Zheng Y, Yang L, Liu S, Zhu J, Zhao N, Pang B, Cao Z, Ma Y. Neutrophil/lymphocyte ratio is helpful for predicting weaning failure: a prospective, observational cohort study. J Thorac Dis. 2018 Sep;10(9):5232-5245. doi: 10.21037/jtd.2018.08.68.
- Individual participant dataSharing planned: No
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.
Zujin Luo, MD contact
Zujin Luo, MD principal investigator
Beijing Chao Yang Hospital
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 Patients Requiring Endotracheal Intubation and Invasive Mechanical Ventilation, run by Beijing Chao Yang Hospital 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 3 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: status not confirmed, as of the sponsor's last update on 2 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zujin Luo, MD (xmjg2002@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weaning failure rate (time frame: 3.5 years). The study lists 3 primary outcomes in all. 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 NCT02981589, 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 2 Jul 2021.