Dexamethasone and the Prevention of Post-Extubation Airway Obstruction in Adults
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Airway Obstruction |
Drug: Dexamethasone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | Mackay Memorial Hospital |
- 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.
| Estimated Enrollment: | 70 |
| Study Start Date: | October 2004 |
| Estimated Study Completion Date: | July 2007 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All patients were > 18 years of age and met the following weaning criteria:
- Temperature ≤ 38°C for > 8 hours,
- Discontinuous use of sedatives,
- Heart rate ≥ 70 and ≤ 130 /min,
- Systolic blood pressure (SBP) ≥ 80 mm Hg in the absence of vasopressors,
- Fraction of inspired oxygen (FiO2) ≤ 0.6, PaO2 ≥ 60, and partial pressure of oxygen (PaO2)/FiO2 ratio > 200,
- Positive end-expiratory pressure (PEEP) ≤ 5 cm H2O,
- Rapid and shallow ratio of frequency to tidal volume (f/VT ≤ 105),
- Minute ventilation ≤ 15 L/min, and
- pH ≥ 7.3. Supplemental oxygen was continued to maintain an oxygen saturation > 95% as measured by a pulse oximeter.
Exclusion Criteria:
- The need for more than one tracheal intubation during the hospital stay,
- Unstable hemodynamics (i.e., a mean SBP < 90 mm Hg, a SBP decrease > 40 mm Hg, or a mean arterial pressure [MAP] < 70 mm Hg),
- Profound recalcitrant hypoxemia (i.e., PaO2 < 60 mm Hg with a FiO2 > 0.50), or
- Administration of corticosteroids 7 days prior to extubation.
Contacts and Locations| Contact: Chao-Hsien Lee, MD | +886-2-23926589 | L49428@ms2.mmh.org.tw |
| Taiwan | |
| Mackay Memorial Hospital | Recruiting |
| Taipei, Taiwan, 104 | |
| Contact: Wan-Ting Chen, Ms +886-2-25433535 ext 2003 wanting.b352@ms1.mmh.org.tw | |
| Principal Investigator: Chao-Hsien Lee, MD | |
| Principal Investigator: | Chao-Hsien Lee, MD | Mackay Memorial Hospital |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00452062 History of Changes |
| Other Study ID Numbers: | MMH-I-S-106 |
| Study First Received: | March 23, 2007 |
| Last Updated: | March 23, 2007 |
| Health Authority: | Taiwan: Institutional Review Board |
Keywords provided by Mackay Memorial Hospital:
|
cuff-leak test intubation corticosteroids dexamethasone to reduce the occurrence of post-extubation airway obstruction |
Additional relevant MeSH terms:
|
Airway Obstruction Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013