Weaning FailureNCT03436095
The Clinical Study of Bundle Measures to Improve the Success Rate of Patients With Difficult Ventilator Weaning
An observational study of Weaning Failure, run by Shenzhen Second People's Hospital at 1 site in China.
Trial summary
Based on nutritional support, Cardiopulmonary rehabilitation and Levosimendan Bundle measures, and making beside checklist of patients with difficult ventilator weaning; Implementation of nutritional risk, respiratory function, and cardiac function assessment prior to weaning; Regulate the procedure to solve the… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Weaning Failure
- What is being tested?
- bundle measures
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2017to 30 Jul 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: difficult-weaning patients with Non neurogenic disease in ICU.
Who may be able to join
- Older than 16 years of age, ventilator therapy more than 1 weeks,ventilator parameters up to Weaning standard, repeated more than 3 times Spontaneous Breathing Test(SBT) not successful, or within a short period of time within a week of successful weaning, no other new incentives to re machine induced delayed more than 1 months or more offline.
- -
Who cannot join
- Mechanical ventilation patients who are clearly defined as neurological disorders or advanced tumor wasting diseases, as well as those without informed consent.
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shenzhen Second People's Hospital
Shenzhen, Guangdong
Yang Guozhao, +86075583003435, yangguozhao123@qq.com
About this study
Based on nutritional support, Cardiopulmonary rehabilitation and Levosimendan Bundle measures, and making beside checklist of patients with difficult ventilator weaning; Implementation of nutritional risk, respiratory function, and cardiac function assessment prior to weaning; Regulate the procedure to solve the problem of difficult-weaning patients with Non neurogenic disease in ICU. Thereby,improve the success rate of weaning patients, so as to shorten the ICU hospitalization time, reduce medical costs, reduce the complications of mechanical ventilation, improve the patient's quality of life.
Read the detailed description
Older than 16 years of age, ventilator therapy more than 1 weeks, Ventilator parameters meet the standard of ventilator removal, repeated more than 3 times SBT not successful, or within a short period of time within a week of successful weaning, no other new incentives to need ventilator support again, and delayed weaning from ventilator more than 1 months.
- Conditions
- Weaning Failure
- Being tested
- bundle measures
- Keywords
- Bundle, difficult ventilator weaning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bundle measuresOther
Implementation of bundle measures to improve the successful rate of weaning ventilator
| Study group | Role | What they receive |
|---|---|---|
| research group | bundle measures to help patient to weaning ventilator Receives: Other: bundle measures | |
| historical control group | retrospect the patients who were difficult to wean from ventilator and collect some materials to compare. Receives: Other: bundle measures | |
| External control group | contrast other same level hospitals measures to patients who are difficult to wean ventilator. Receives: Other: bundle measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bundle measures can solve the problem of difficult-weaning patients with Non neurogenic disease in ICU.
Based on nutritional support, Cardiopulmonary rehabilitation and Levosimendan Bundle measures, and making beside checklist of patients with difficult ventilator weaning; Implementation of nutritional risk, respiratory function, and cardiac function assessment prior to weaning; Regulate the procedure to solve the problem of difficult-weaning patients with Non neurogenic disease in ICU. Thereby,improve the success rate of weaning patients, so as to shorten the ICU hospitalization time, reduce medical costs, reduce the complications of mechanical ventilation, improve the patient's quality of life.
Measured: From June 1st 2017 to June 30 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start25 Jan 2017
- Primary completion30 Nov 2019 (estimated)
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning FailureStudies 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Second People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meng Xinke, Study director, study principal investigator Shenzhen Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436095
- Sponsor's protocol ID
- 20173357201816
- Status last verified
- Feb 2018
- First submitted
- 10 Feb 2018
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Study of Bundle Measures to Improve the Success Rate of Patients With Difficult Ventilator Weaning
- ClinicalTrials.gov ID
- NCT03436095
- Acronym / sponsor ID
- 20173357201816
- Conditions
- Weaning Failure
- Keywords
- Bundle, difficult ventilator weaning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shenzhen Second People's HospitalUniversity, hospital or other
- Study start
- 25 Jan 2017 (actual)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 19 Feb 2018 (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.
Based on nutritional support, Cardiopulmonary rehabilitation and Levosimendan Bundle measures, and making beside checklist of patients with difficult ventilator weaning; Implementation of nutritional risk, respiratory function, and cardiac function assessment prior to weaning; Regulate the procedure to solve the problem of difficult-weaning patients with Non neurogenic disease in ICU. Thereby,improve the success rate of weaning patients, so as to shorten the ICU hospitalization time, reduce medical costs, reduce the complications of mechanical ventilation, improve the patient's quality of life.
Detailed description
Older than 16 years of age, ventilator therapy more than 1 weeks, Ventilator parameters meet the standard of ventilator removal, repeated more than 3 times SBT not successful, or within a short period of time within a week of successful weaning, no other new incentives to need ventilator support again, and delayed weaning from ventilator more than 1 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| research group | – | Other: bundle measuresbundle measures to help patient to weaning ventilator |
| historical control group | – | Other: bundle measuresretrospect the patients who were difficult to wean from ventilator and collect some materials to compare. |
| External control group | – | Other: bundle measurescontrast other same level hospitals measures to patients who are difficult to wean ventilator. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- difficult-weaning patients with Non neurogenic disease in ICU.
Key inclusion criteria (2 listed)
- Older than 16 years of age, ventilator therapy more than 1 weeks,ventilator parameters up to Weaning standard, repeated more than 3 times Spontaneous Breathing Test(SBT) not successful, or within a short period of time within a week of successful weaning, no other new incentives to re machine induced delayed more than 1 months or more offline.
- -
Key exclusion criteria (2 listed)
- Mechanical ventilation patients who are clearly defined as neurological disorders or advanced tumor wasting diseases, as well as those without informed consent.
- -
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 |
|---|---|---|
| bundle measuresImplementation of bundle measures to improve the successful rate of weaning ventilator | Other | External control group, historical control group, research group |
Primary outcome
Bundle measures can solve the problem of difficult-weaning patients with Non neurogenic disease in ICU.
Time frame: From June 1st 2017 to June 30 2020
Based on nutritional support, Cardiopulmonary rehabilitation and Levosimendan Bundle measures, and making beside checklist of patients with difficult ventilator weaning; Implementation of nutritional risk, respiratory function, and cardiac function assessment prior to weaning; Regulate the procedure to solve the problem of difficult-weaning patients with Non neurogenic disease in ICU. Thereby,improve the success rate of weaning patients, so as to shorten the ICU hospitalization time, reduce medical costs, reduce the complications of mechanical ventilation, improve the patient's quality of life.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- 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.
Meng Xinke study director
study principal investigator Shenzhen Second 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 Weaning Failure, run by Shenzhen Second People's 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 2 inclusion and 2 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 19 Feb 2018. 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 Feng Yongwen (13902471022, 29206961@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bundle measures can solve the problem of difficult-weaning patients with Non neurogenic disease in ICU. (time frame: From June 1st 2017 to June 30 2020). 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 19 Feb 2018.