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

Study Overview
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Brief Summary
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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 Description
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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.

Official Title
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Phase 2 Study of Comparison of High Dose and Low Dose Dexamethasone in Preventing Post-Extubation Airway Obstruction in Adults

Conditions
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Airway Obstruction

Intervention / Treatment
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* Drug: dexamethasone (Oradexon, Nederland)


Participation Criteria
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Eligibility Criteria
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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: A history of extubation during the same hospitalization Administration of corticosteroids seven days prior to extubation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>dexamethasone 5mg was administered every 6 hour for 1 day | Drug: dexamethasone (Oradexon, Nederland)<br>* dexamethasone 5mg was administered every 6 hour for 1 day in group 1 and dexamethasone 10mg was administered every 6 hour for 1 day in group 2<br>|
| Active Comparator: 2<br>dexamethasone 10mg was administered every 6 hour for 1 day | Drug: dexamethasone (Oradexon, Nederland)<br>* dexamethasone 5mg was administered every 6 hour for 1 day in group 1 and dexamethasone 10mg was administered every 6 hour for 1 day in group 2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| absolute cuff leak volumes and relative cuff leak volume to tidal volume(%)(measured CLV-baseline CLV) X 100/ tidal volume) |  | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endotracheal intubation, Laryngeal edema, Cuff-leak test, Corticosteroids, This study was to ascertain whether administration of dexamethasone to critically intubated patients prevent postextubation airway obstruction., This study was to compare high dose and low dose dexamethasone in preventing noninvasive ventilation or reintubation among critically ill intubated patients