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

Mackay Memorial Hospital80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Airway Obstruction

Interventions

dexamethasone (Oradexon, Nederland)DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 Years

Medical Language ↔ Plain English

Inclusion Criteria: All patients were \> 18 years of age and met the following weaning criteria: 1. Temperature ≤ 38°C for \> 8 hours, 2. Discontinuous use of sedatives, 3. Heart rate ≥ 70 and ≤ 130 /min, 4. Systolic blood pressure (SBP) ≥ 80 mm Hg in the absence of vasopressors, 5. Fraction of inspired oxygen (FiO2) ≤ 0.6, PaO2 ≥ 60, and partial pressure of oxygen (PaO2)/FiO2 ratio \> 200, 6. Positive end-expiratory pressure (PEEP) ≤ 5 cm H2O, 7. Rapid and shallow ratio of frequency to tidal volume (f/VT ≤ 105), 8. Minute ventilation ≤ 15 L/min, and 9. pH ≥ 7.3. Supplemental oxygen was continued to maintain an oxygen saturation \> 95% as measured by a pulse oximeter. Exclusion Criteria: 1. A history of extubation during the same hospitalization 2. Administration of corticosteroids seven days prior to extubation.

Locations (1)

No. 92, SEC. 2, CHUNG SHAN N. RD, TAIPEI, TAIWAN.

Taipei, Taiwan

RECRUITING

Outcomes

Primary Outcomes

absolute cuff leak volumes and relative cuff leak volume to tidal volume(%)(measured CLV-baseline CLV) X 100/ tidal volume)

Time frame: 48 hours

Central Contacts

Chao-Hsien Lee, MD

CONTACT

+886-2-23926589 L49428@ms2.mmh.org.tw

Data from ClinicalTrials.gov

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