Comparison of High Dose and Low Dose Dexamethasone in Preventing Post-Extubation Airway Obstruction in Adults
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | October 23, 2007 | ||||
| Last Updated Date | May 27, 2008 | ||||
| Start Date ICMJE | April 2007 | ||||
| Estimated Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
absolute cuff leak volumes and relative cuff leak volume to tidal volume(%)(measured CLV-baseline CLV) X 100/ tidal volume) [ Time Frame: 48 hours ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00548483 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparison of High Dose and Low Dose Dexamethasone in Preventing Post-Extubation Airway Obstruction in Adults | ||||
| Official Title ICMJE | Phase 2 Study of Comparison of High Dose and Low Dose Dexamethasone in Preventing Post-Extubation Airway Obstruction in Adults | ||||
| Brief Summary | The specific objectives were to determine whether high dose dexamethasone are more effective than low dose dexamethasone in the reduction or prevention of post-extubation airway obstruction among patients with a cuff leak volume (CLV) < 110 mL. |
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| Detailed Description | Controversy currently exists regarding the effectiveness of prophylactic steroid therapy for patients considered at high risk for post-extubation stridor. Studies regarding the efficacy of prophylactic corticosteroids for intubated patients have yielded conflicting results due to differences in the number, dose, or type of corticosteroids administered. Only a limited number of prospective trials involving adults and evaluating the benefits and the dose of corticosteroid therapy prior to extubation have been conducted.The present study was conducted to evaluate the effects of prophylactic dexamethasone therapy for a subset of high-risk patients who had been intubated for > 48 hours and who were undergoing their first elective extubation in an ICU setting. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
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| Condition ICMJE | Airway Obstruction | ||||
| Intervention ICMJE | Drug: dexamethasone (Oradexon, Nederland)
dexamethasone 5mg was administered every 6 hour for 1 day in group 1 and dexamethasone 10mg was administered every 6 hour for 1 day in group 2 |
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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 | 80 | ||||
| Estimated Completion Date | May 2008 | ||||
| Estimated Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: All patients were > 18 years of age and met the following weaning criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 95 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00548483 | ||||
| Other Study ID Numbers ICMJE | MMH-I-S-107 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Chao-Hsien, Lee, Mackay memorial hospital | ||||
| Study Sponsor ICMJE | Mackay Memorial Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Mackay Memorial Hospital | ||||
| Verification Date | May 2008 | ||||
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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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