Mechanical VentilationNCT03118804
Weaning From Mechanical Ventilation Guide by Assessment of Lung Tidal Distribution With EIT
An observational study of Mechanical Ventilation, run by Southeast University, China at 1 site in China.
Trial summary
To evaluate whether EELI, RVD, GI were good predictor for weaning from mechanical ventilation Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- Assessment of Lung Tidal Distribution With EIT
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2016to 31 Dec 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with mechanical ventilation admitted to ICU of Zhongda hospital
Who may be able to join
- Intubated patients age between 18 years old and 80 years old
- Duration of controlled mechanical ventilation≥ 24 h
- Patients ready to wean from mechanical ventilation
- Informed consent
Who cannot join
- Pregnant women
- Patients with malignant tumor
- High paraplegia, neuromuscular lesions
- Thoracic deformity, diaphragmatic hernia
- Patients with ECMO
- Patient participated in another interventional trial before enrollment
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate whether EELI, RVD, GI were good predictor for weaning from mechanical ventilation
Read the detailed description
53 patients who ready to wean from mechanical ventilation were included in this study. The changes of lung tidal distribution during SBT with mechanical ventilation by EIT were recorded. Whether EELI, RVD, GI were good predictor for weaning from mechanical ventilation?
- Conditions
- Mechanical Ventilation
- Being tested
- Assessment of Lung Tidal Distribution With EIT
- Keywords
- Weaning, Mechanical ventilation, Electrical impedance tomography, Tidal distribution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of Lung Tidal Distribution With EITDiagnostic test
Changes of lung tidal distribution during SBT with mechanical ventilation were recorded by EIT can be used to predict weaning success or failure
| Study group | Role | What they receive |
|---|---|---|
| Weaning Guide by EIT | Weaning From Mechanical Ventilation Guide by Assessment of Lung Tidal Distribution With EIT Receives: Diagnostic Test: Assessment of Lung Tidal Distribution With EIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weaning duration
Time of weaning duration from SBT to weaning from mechanical ventilation
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start18 Oct 2016
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songqiao Liu, Southeast University, China
- Investigators
- Liu Songqiao, PHD, Principal investigator, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118804
- Sponsor's protocol ID
- 2016ZDSYLL064-Y01
- Status last verified
- Nov 2022
- First submitted
- 9 Apr 2017
- Last updated
- 30 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weaning From Mechanical Ventilation Guide by Assessment of Lung Tidal Distribution With EIT
- ClinicalTrials.gov ID
- NCT03118804
- Acronym / sponsor ID
- 2016ZDSYLL064-Y01
- Conditions
- Mechanical Ventilation
- Keywords
- Weaning, Mechanical ventilation, Electrical impedance tomography, Tidal distribution
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 18 Oct 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 18 Apr 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.
To evaluate whether EELI, RVD, GI were good predictor for weaning from mechanical ventilation
Detailed description
53 patients who ready to wean from mechanical ventilation were included in this study. The changes of lung tidal distribution during SBT with mechanical ventilation by EIT were recorded. Whether EELI, RVD, GI were good predictor for weaning from mechanical ventilation?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Weaning Guide by EIT | – | Diagnostic Test: Assessment of Lung Tidal Distribution With EITWeaning From Mechanical Ventilation Guide by Assessment of Lung Tidal Distribution With EIT |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with mechanical ventilation admitted to ICU of Zhongda hospital
Key inclusion criteria (4 listed)
- Intubated patients age between 18 years old and 80 years old
- Duration of controlled mechanical ventilation≥ 24 h
- Patients ready to wean from mechanical ventilation
- Informed consent
Key exclusion criteria (6 listed)
- Pregnant women
- Patients with malignant tumor
- High paraplegia, neuromuscular lesions
- Thoracic deformity, diaphragmatic hernia
- Patients with ECMO
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 |
|---|---|---|
| Assessment of Lung Tidal Distribution With EITChanges of lung tidal distribution during SBT with mechanical ventilation were recorded by EIT can be used to predict weaning success or failure | Diagnostic test | Weaning Guide by EIT |
Primary outcome
Weaning duration
Time frame: 48 hours
Time of weaning duration from SBT to weaning from mechanical ventilation
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 30 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Liu Songqiao, PHD principal investigator
Southeast University
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 Mechanical Ventilation, run by Southeast University, China 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 4 inclusion and 6 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 30 Nov 2022. 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?
Weaning duration (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Nov 2022.