drugset / Trial / NCT00452062

Dexamethasone and the Prevention of Post-Extubation Airway Obstruction in Adults

NCT00452062 ↗

Phase 2 Unknown 70 enrolled Mackay Memorial Hospital
RandomizedParallel-groupDouble-blindPrevention

Summary

Laryngotracheal injury related to intubation may cause narrowing of the airway due to edema of the glottis. Post-extubation airway frequently necessitating re-intubation and resulting in the prolongation of intensive care. Factors correlating with the development of post-extubation stridor include age, female gender, an elevated Acute Physiologic and Chronic Health Evaluation II, trauma related to endotracheal intubation, excessive ETT size, unnecessary tube mobility, increased cuff pressure, frequent tracheal aspirations, infection, arterial hypotension, and a prolonged intubation period. Because the presence of an endotracheal tube (ETT) precludes direct visualization of the upper airway, recognition of edema due to laryngotracheal injury is often difficult. However, upper airway patency may be measured indirectly in the intubated patient by documentation of a leak around the ETT upon deflation of the sealing balloon cuff encircling the ETT. Controversy currently exists regarding the effectiveness of prophylactic steroid therapy for patients considered at high risk for post-extubation stridor. Only a limited number of prospective trials involving adults and evaluating the benefits of corticosteroid therapy prior to extubation have been conducted. Studies regarding the efficacy of prophylactic corticosteroids for intubated patients have yielded conflicting results due to differences in the number of doses or types of corticosteroids administered. 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. The specific objectives were to determine whether multiple doses of dexamethasone are effective in the reduction or prevention of post-extubation airway obstruction in patients with a cuff leak volume (CLV) \< 110 mL and to ascertain whether an aftereffect follows the discontinuation of dexamethasone.

Timeline

Start
2004-10
Primary completion
—
Completion
2007-07

Outcome

Met primary endpoint

paper The incidence of postextubation stridor was significantly lower in the dexamethasone group than in the placebo group (10% [4/40] versus 27.5% [11/40]; p = 0.037). PMID 17605780 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 5 mg Intravenous