NCT00548483

Comparison of High Dose and Low Dose Dexamethasone in Preventing Post-Extubation Airway Obstruction in Adults

Phase 2 Study of Comparison of High Dose and Low Dose Dexamethasone in Preventing Post-Extubation Airway Obstruction in Adults

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Mackay Memorial Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Airway Obstruction

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-04-01
• Primary completion: 2008-03-01
• Completion: 2008-05-01
• First posted: 2007-10-24
• Last updated: 2008-05-28

Locations

1 site across 1 country: Taiwan