Comparison of High Dose and Low Dose Dexamethasone in Preventing Post-Extubation Airway Obstruction in Adults
NCT ID: NCT00548483
Last Updated: 2008-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2007-04-30
2008-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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1
dexamethasone 5mg was administered every 6 hour for 1 day
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
2
dexamethasone 10mg was administered every 6 hour for 1 day
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
1. Temperature ≤ 38°C for \> 8 hours,
2. Discontinuous use of sedatives,
3. Heart rate ≥ 70 and ≤ 130 /min,
4. Systolic blood pressure (SBP) ≥ 80 mm Hg in the absence of vasopressors,
5. Fraction of inspired oxygen (FiO2) ≤ 0.6, PaO2 ≥ 60, and partial pressure of oxygen (PaO2)/FiO2 ratio \> 200,
6. Positive end-expiratory pressure (PEEP) ≤ 5 cm H2O,
7. Rapid and shallow ratio of frequency to tidal volume (f/VT ≤ 105),
8. Minute ventilation ≤ 15 L/min, and
9. pH ≥ 7.3. Supplemental oxygen was continued to maintain an oxygen saturation \> 95% as measured by a pulse oximeter.
Exclusion Criteria
2. Administration of corticosteroids seven days prior to extubation.
18 Years
95 Years
ALL
No
Sponsors
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Mackay Memorial Hospital
OTHER
Responsible Party
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Mackay memorial hospital
Principal Investigators
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Chao-Hsien Lee, MD
Role: PRINCIPAL_INVESTIGATOR
Mackay Memorial Hospital
Locations
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No. 92, SEC. 2, CHUNG SHAN N. RD, TAIPEI, TAIWAN.
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Chao-Hsien Lee, MD
Role: primary
References
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Lee CH, Peng MJ, Wu CL. Dexamethasone to prevent postextubation airway obstruction in adults: a prospective, randomized, double-blind, placebo-controlled study. Crit Care. 2007;11(4):R72. doi: 10.1186/cc5957.
Cheng KC, Hou CC, Huang HC, Lin SC, Zhang H. Intravenous injection of methylprednisolone reduces the incidence of postextubation stridor in intensive care unit patients. Crit Care Med. 2006 May;34(5):1345-50. doi: 10.1097/01.CCM.0000214678.92134.BD.
Francois B, Bellissant E, Gissot V, Desachy A, Normand S, Boulain T, Brenet O, Preux PM, Vignon P; Association des Reanimateurs du Centre-Ouest (ARCO). 12-h pretreatment with methylprednisolone versus placebo for prevention of postextubation laryngeal oedema: a randomised double-blind trial. Lancet. 2007 Mar 31;369(9567):1083-9. doi: 10.1016/S0140-6736(07)60526-1.
Other Identifiers
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MMH-I-S-107
Identifier Type: -
Identifier Source: org_study_id