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

NCT00452062 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2007-03-26

No results posted yet for this study

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.

Conditions

  • Airway Obstruction

Interventions

DRUG

Dexamethasone

Sponsors & Collaborators

  • Mackay Memorial Hospital

    lead OTHER

Principal Investigators

  • Chao-Hsien Lee, MD · Mackay Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Completion
2007-07-31

Countries

  • Taiwan

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00452062 on ClinicalTrials.gov