Weaning FailureweaningNCT01867853
Volume Responsiveness Before SBT Predicts the Outcome of Mechanical Ventilation Weaning in Critically Ill Patients
An observational study of Weaning Failure, run by Southeast University, China at 1 site in China.
Trial summary
To evaluate the performance of volume responsiveness in predicting the outcome of mechanical ventilation weaning in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weaning Failure
- What is being tested?
- PLR
- Type of treatment
- Medical device
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- Oct 2012to Mar 2013
- How long will I take part?
- 6 Months
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients were mechanically ventilated and ready to undergo a spontaneous breathing trial (SBT) with a T-piece
Who may be able to join
- mechanical ventilation
Who cannot join
- pregnancy or breast-feeding
- tracheostomy at baseline
- myasthenia gravis or acute polyradiculoneuropathy
- end-stage chronic illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Volume Responsiveness Before Spontaneous Breath Trial Predicts the Outcome of Mechanical Ventilation Weaning in Critically Ill Patients
To evaluate the performance of volume responsiveness in predicting the outcome of mechanical ventilation weaning in critically ill patients.
Read the detailed description
82 patients, 61 succeed and 21 failed
- Conditions
- Weaning Failure
- Being tested
- PLR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLRDevice
Also called passive leg raising
passive leg raising test was done before and at the end of SBT
| Study group | Role | What they receive |
|---|---|---|
| successful weaning | the SUCCESS of SBT or not need for reintubation or noninvasive ventilation within 48 h following extubation Receives: Device: PLR | |
| failed weaning | the failure of SBT or the need for reintubation or noninvasive ventilation within 48 h following extubation Receives: Device: PLR |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of cardiac index
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startOct 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Collaborators
- Zhongda Hospital
- Responsible party
- Principal investigator, Jianfeng Xie, Southeast University, China
- Investigators
- Zhimin DOU, Principal investigator, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867853
- Sponsor's protocol ID
- 10286
- Acronym
- weaning
- Status last verified
- Jun 2013
- First submitted
- 6 May 2013
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
MacIntyre N. Discontinuing mechanical ventilatory support. Chest. 2007 Sep;132(3):1049-56. doi: 10.1378/chest.06-2862.
PubMed 17873200Eskandar N, Apostolakos MJ. Weaning from mechanical ventilation. Crit Care Clin. 2007 Apr;23(2):263-74, x. doi: 10.1016/j.ccc.2006.12.002.
PubMed 17368170MacIntyre NR, Cook DJ, Ely EW Jr, Epstein SK, Fink JB, Heffner JE, Hess D, Hubmayer RD, Scheinhorn DJ; American College of Chest Physicians; American Association for Respiratory Care; American College of Critical Care Medicine. Evidence-based guidelines for weaning and discontinuing ventilatory support: a collective task force facilitated by the American College of Chest Physicians; the American Association for Respiratory Care; and the American College of Critical Care Medicine. Chest. 2001 Dec;120(6 Suppl):375S-95S. doi: 10.1378/chest.120.6_suppl.375s. No abstract available.
PubMed 11742959Monnet X, Teboul JL, Richard C. Cardiopulmonary interactions in patients with heart failure. Curr Opin Crit Care. 2007 Feb;13(1):6-11. doi: 10.1097/MCC.0b013e328013c865.
PubMed 17198043Teboul JL, Monnet X. Detecting volume responsiveness and unresponsiveness in intensive care unit patients: two different problems, only one solution. Crit Care. 2009;13(4):175. doi: 10.1186/cc7979. Epub 2009 Aug 10.
PubMed 19678915Monnet X, Teboul JL. Passive leg raising. Intensive Care Med. 2008 Apr;34(4):659-63. doi: 10.1007/s00134-008-0994-y. Epub 2008 Jan 23.
PubMed 18214429
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volume Responsiveness Before Spontaneous Breath Trial Predicts the Outcome of Mechanical Ventilation Weaning in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT01867853
- Acronym / sponsor ID
- weaning / 10286
- Conditions
- Weaning Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Collaborators
- Zhongda Hospital
- Study start
- Oct 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 4 Jun 2013 (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 performance of volume responsiveness in predicting the outcome of mechanical ventilation weaning in critically ill patients.
Detailed description
82 patients, 61 succeed and 21 failed
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| successful weaning | – | Device: PLRthe SUCCESS of SBT or not need for reintubation or noninvasive ventilation within 48 h following extubation |
| failed weaning | – | Device: PLRthe failure of SBT or the need for reintubation or noninvasive ventilation within 48 h following extubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients were mechanically ventilated and ready to undergo a spontaneous breathing trial (SBT) with a T-piece
Key inclusion criteria (1 listed)
- mechanical ventilation
Key exclusion criteria (4 listed)
- pregnancy or breast-feeding
- tracheostomy at baseline
- myasthenia gravis or acute polyradiculoneuropathy
- end-stage chronic illness
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 |
|---|---|---|
| PLRAlso: passive leg raisingpassive leg raising test was done before and at the end of SBT | Device | failed weaning, successful weaning |
Primary outcome
changes of cardiac index
Time frame: 30 minutes
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 5 Jun 2013.
- Results publication: PubMed 17873200MacIntyre N. Discontinuing mechanical ventilatory support. Chest. 2007 Sep;132(3):1049-56. doi: 10.1378/chest.06-2862.
- Results publication: PubMed 17368170Eskandar N, Apostolakos MJ. Weaning from mechanical ventilation. Crit Care Clin. 2007 Apr;23(2):263-74, x. doi: 10.1016/j.ccc.2006.12.002.
- Results publication: PubMed 11742959MacIntyre NR, Cook DJ, Ely EW Jr, Epstein SK, Fink JB, Heffner JE, Hess D, Hubmayer RD, Scheinhorn DJ; American College of Chest Physicians; American Association for Respiratory Care; American College of Critical Care Medicine. Evidence-based guidelines for weaning and discontinuing ventilatory support: a collective task force facilitated by the American College of Chest Physicians; the American Association for Respiratory Care; and the American College of Critical Care Medicine. Chest. 2001 Dec;120(6 Suppl):375S-95S. doi: 10.1378/chest.120.6_suppl.375s. No abstract available.
- Results publication: PubMed 17198043Monnet X, Teboul JL, Richard C. Cardiopulmonary interactions in patients with heart failure. Curr Opin Crit Care. 2007 Feb;13(1):6-11. doi: 10.1097/MCC.0b013e328013c865.
- Results publication: PubMed 19678915Teboul JL, Monnet X. Detecting volume responsiveness and unresponsiveness in intensive care unit patients: two different problems, only one solution. Crit Care. 2009;13(4):175. doi: 10.1186/cc7979. Epub 2009 Aug 10.
- Results publication: PubMed 18214429Monnet X, Teboul JL. Passive leg raising. Intensive Care Med. 2008 Apr;34(4):659-63. doi: 10.1007/s00134-008-0994-y. Epub 2008 Jan 23.
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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.
Zhimin DOU 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 Weaning Failure, 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 1 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: finished, as of the sponsor's last update on 5 Jun 2013. 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?
changes of cardiac index (time frame: 30 minutes). 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 NCT01867853, which also lists 6 linked publications.
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 5 Jun 2013.