Pressure Support Reduction Versus Spontaneous Breathing Trials in Weaning From Ventilation
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Postgraduate Institute of Medical Education and Research.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Postgraduate Institute of Medical Education and Research
Information provided by:
Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT00911378
First received: May 28, 2009
Last updated: June 19, 2009
Last verified: June 2009
| Tracking Information | |||||
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| First Received Date ICMJE | May 28, 2009 | ||||
| Last Updated Date | June 19, 2009 | ||||
| Start Date ICMJE | April 2008 | ||||
| Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Rate of weaning failure [ Time Frame: 48 hours from extubation ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00911378 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Pressure Support Reduction Versus Spontaneous Breathing Trials in Weaning From Ventilation | ||||
| Official Title ICMJE | A Randomized Controlled Trial on Weaning by Pressure Support Reduction Versus Spontaneous Breathing Trials in a Respiratory ICU | ||||
| Brief Summary | This study is a comparison of two most commonly used modes of weaning and the outcomes in the two groups. |
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| Detailed Description | Patients ventilated for more than 24 hours are randomized into two groups - one group of patients undergo gradual reduction of pressure support and in the other, T tube trials are used for weaning. The outcomes are compared in the two groups. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Health Services Research |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 130 | ||||
| Estimated Completion Date | September 2009 | ||||
| Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 10 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | India | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00911378 | ||||
| Other Study ID Numbers ICMJE | weaning2009 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Dr. Ritesh Agarwal, Postgraduate Institute of Medical Education and Research | ||||
| Study Sponsor ICMJE | Postgraduate Institute of Medical Education and Research | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Postgraduate Institute of Medical Education and Research | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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