- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01867853
Volume Responsiveness Before SBT Predicts the Outcome of Mechanical Ventilation Weaning in Critically Ill Patients (weaning)
June 3, 2013 updated by: Jianfeng Xie, Southeast University, China
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.
Study Overview
Detailed Description
82 patients, 61 succeed and 21 failed
Study Type
Observational
Enrollment (Actual)
82
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Jiangsu
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Nanjing, Jiangsu, China, 210009
- Zhongda Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The patients were mechanically ventilated and ready to undergo a spontaneous breathing trial (SBT) with a T-piece
Description
Inclusion Criteria:
- mechanical ventilation
Exclusion Criteria:
- pregnancy or breast-feeding
- tracheostomy at baseline
- myasthenia gravis or acute polyradiculoneuropathy
- end-stage chronic illness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
successful weaning
the SUCCESS of SBT or not need for reintubation or noninvasive ventilation within 48 h following extubation
|
passive leg raising test was done before and at the end of SBT
Other Names:
|
|
failed weaning
the failure of SBT or the need for reintubation or noninvasive ventilation within 48 h following extubation
|
passive leg raising test was done before and at the end of SBT
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
changes of cardiac index
Time Frame: 30 minutes
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Zhimin DOU, Southeast university
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- MacIntyre 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.
- MacIntyre N. Discontinuing mechanical ventilatory support. Chest. 2007 Sep;132(3):1049-56. doi: 10.1378/chest.06-2862.
- Eskandar 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.
- Monnet 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.
- Teboul 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.
- Monnet 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
May 6, 2013
First Submitted That Met QC Criteria
May 29, 2013
First Posted (Estimate)
June 4, 2013
Study Record Updates
Last Update Posted (Estimate)
June 5, 2013
Last Update Submitted That Met QC Criteria
June 3, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10286
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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