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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: 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.

Detailed Summary:

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.

Sponsor: Mackay Memorial Hospital

Current Primary Outcome: absolute cuff leak volumes and relative cuff leak volume to tidal volume(%)(measured CLV-baseline CLV) X 100/ tidal volume) [ Time Frame: 48 hours ]

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Mackay Memorial Hospital

Dates:
Date Received: October 23, 2007
Date Started: April 2007
Date Completion: May 2008
Last Updated: May 27, 2008
Last Verified: May 2008