Dexamethasone and the Prevention of Post-Extubation Airway Obstruction in Adults
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|ClinicalTrials.gov Identifier: NCT00452062|
Recruitment Status : Unknown
Verified March 2007 by Mackay Memorial Hospital.
Recruitment status was: Recruiting
First Posted : March 26, 2007
Last Update Posted : March 26, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Airway Obstruction||Drug: Dexamethasone||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Mackay Memorial Hospital|
|Study Start Date :||October 2004|
|Estimated Study Completion Date :||July 2007|
- The purpose of this study was to ascertain whether administration of multiple doses of dexamethasone to critically ill intubated patients reduces or prevents the occurrence of post-extubation airway obstruction.
- The secondary purpose of this study was to ascertain whether administration of multiple doses of dexamethasone to critically ill intubated patients reduces or prevents the occurrence of noninvasive ventilation or re-intubation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00452062
|Contact: Chao-Hsien Lee, MD||+886-2-23926589||L49428@ms2.mmh.org.tw|
|Mackay Memorial Hospital||Recruiting|
|Taipei, Taiwan, 104|
|Contact: Wan-Ting Chen, Ms +886-2-25433535 ext 2003 firstname.lastname@example.org|
|Principal Investigator: Chao-Hsien Lee, MD|
|Principal Investigator:||Chao-Hsien Lee, MD||Mackay Memorial Hospital|