Intensive Care MedicineNCT02487927
The Classification of Difficult Weaning and the Predictive Value of Relative Factors for Difficult Weaning
An observational study of Intensive Care Medicine and Mechanical Ventilation, run by Jianfeng Xie at 1 site in China.
Trial summary
To evaluate the distribution of different types of difficult weaning and the predictive value of weaning relative factors. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Intensive Care Medicine, Mechanical Ventilation, Weaning
- What is being tested?
- weaning
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- Jun 2012to Jul 2015
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: mechanical vetilation patients in ICU, and the patients are weaninng candidates
Who may be able to join
- mechanical ventilation patients
- prepared to weaning
- sign on the acknowledged
Who cannot join
- endotracheotomy
- single lung
- pregnant
- heart,liver,renal failure
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital
Nanjing, Jiangsu, 210009
Haibo Qiu, Prof, +862583262550, haiboq2000@163.com
About this study
To evaluate the distribution of different types of difficult weaning and the predictive value of weaning relative factors.
Read the detailed description
108 patients who passed the spontaneous breathing test (SBT) were included in this study,every patient were performed 30-60 minutes SBT after enrollment.Patients were divided into succeed weaning and difficult weaning group according the results of SBT, the difficult weaning group were futher divided into A(Airway and Lung dysfunction),B（Brain dysfunction）,C（Cardic dysfunction）,D（Diaphragm dysfunction）,E（Endocrine and metabolic dysfunction）five different groups according to the causes of difficult weaning. The respiratory mechanical parameters,the diameter of inferior vena cava and the diaphgram excursion were recorded before SBT and 30 minutes after SBT.
- Conditions
- Intensive Care Medicine, Mechanical Ventilation, Weaning
- Being tested
- weaning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weaningBehavioural
T piece
| Study group | Role | What they receive |
|---|---|---|
| Weaning success | patients pass SBT and weaning without any ventilation in 48 hours Receives: Behavioral: weaning | |
| weaning failure | patients do not pass SBT or ventilation with any ventilation in 48 hours Receives: Behavioral: weaning |
What is being measured
The primary outcome is the main question the study is designed to answer.
the reasons of difficult weaning
Measured: 30 mins
Secondary outcomes (1)
The predictive value of diaphragm associated values in weaning
Measured: 30mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startJun 2012
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care MedicineStudies 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jianfeng Xie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jianfeng Xie, Southeast University, China
- Investigators
- Haibo Qiu, Dr, Study director, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487927
- Sponsor's protocol ID
- Weaning Study
- Status last verified
- Jun 2015
- First submitted
- 23 Jun 2015
- Last updated
- 2 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Classification of Difficult Weaning and the Predictive Value of Relative Factors for Difficult Weaning
- ClinicalTrials.gov ID
- NCT02487927
- Acronym / sponsor ID
- Weaning Study
- Conditions
- Intensive Care Medicine, Mechanical Ventilation, Weaning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Jianfeng XieUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 2 Jul 2015 (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.
To evaluate the distribution of different types of difficult weaning and the predictive value of weaning relative factors.
Detailed description
108 patients who passed the spontaneous breathing test (SBT) were included in this study,every patient were performed 30-60 minutes SBT after enrollment.Patients were divided into succeed weaning and difficult weaning group according the results of SBT, the difficult weaning group were futher divided into A(Airway and Lung dysfunction),B（Brain dysfunction）,C（Cardic dysfunction）,D（Diaphragm dysfunction）,E（Endocrine and metabolic dysfunction）five different groups according to the causes of difficult weaning. The respiratory mechanical parameters,the diameter of inferior vena cava and the diaphgram excursion were recorded before SBT and 30 minutes after SBT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weaning success | – | Behavioral: weaningpatients pass SBT and weaning without any ventilation in 48 hours |
| weaning failure | – | Behavioral: weaningpatients do not pass SBT or ventilation with any ventilation in 48 hours |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- mechanical vetilation patients in ICU, and the patients are weaninng candidates
Key inclusion criteria (3 listed)
- mechanical ventilation patients
- prepared to weaning
- sign on the acknowledged
Key exclusion criteria (4 listed)
- endotracheotomy
- single lung
- pregnant
- heart,liver,renal failure
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 |
|---|---|---|
| weaningT piece | Behavioural | Weaning success, weaning failure |
Primary outcome
the reasons of difficult weaning
Time frame: 30 mins
1 secondary outcome
The predictive value of diaphragm associated values in weaning
Time frame: 30mins
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2015.
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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.
Haibo Qiu, Dr study director
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 Intensive Care Medicine and Mechanical Ventilation, run by Jianfeng Xie 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 3 inclusion and 4 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 2015. 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 Jianfeng Xie, Dr (+862583262550, panchun1982@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the reasons of difficult weaning (time frame: 30 mins). 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 2 Jul 2015.